<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04490109</url>
  </required_header>
  <id_info>
    <org_study_id>PRB244-01</org_study_id>
    <nct_id>NCT04490109</nct_id>
  </id_info>
  <brief_title>B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis</brief_title>
  <official_title>A Phase II, Randomized, Double-Blind, Vehicle Controlled Study of the Efficacy, Safety, and Tolerability of B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>bioRASI, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AOBiome LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety,&#xD;
      and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of&#xD;
      atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1&#xD;
      ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle&#xD;
      (placebo) for 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II&#xD;
      Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle&#xD;
      applications on treatment of mild to moderate pruritus associated with atopic dermatitis.&#xD;
&#xD;
        -  Approximately 576 subjects may be enrolled.&#xD;
&#xD;
        -  The total duration of the study will be approximately 11 weeks. Participants will report&#xD;
           for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go&#xD;
           through a two-week washout phase before reporting for a Baseline visit.&#xD;
&#xD;
        -  After screening and baseline, participants will be randomized to one of two doses of&#xD;
           B244 or vehicle application for 4 weeks.&#xD;
&#xD;
        -  Randomization will be 1:1:1 so that an equal number of patients will be treated in each&#xD;
           Arm of the study.&#xD;
&#xD;
        -  All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0&#xD;
&#xD;
        -  Subjects must be willing and able to complete diary within a consistent time frame on a&#xD;
           daily basis and to comply with restrictions on allowable therapies for the duration of&#xD;
           the study.&#xD;
&#xD;
        -  All subjects will attend a screening visit not more than 21 days prior to Baseline (Day&#xD;
           0).&#xD;
&#xD;
        -  Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day&#xD;
           28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4&#xD;
           weeks (28 (±3) days) after the last dose of study medication.&#xD;
&#xD;
        -  Subjects will apply a total of 10 pumps of IP per application across all affected areas&#xD;
           twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks.&#xD;
&#xD;
        -  Safety evaluations will consist of review of participant's medical history at screening&#xD;
           and on-going assessment of adverse events reported throughout the study duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">January 7, 2022</completion_date>
  <primary_completion_date type="Actual">December 10, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in WI-NRS from baseline to Week 4</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessing the efficacy of B244 by measuring the mean change in WI-NRS reported by subjects from baseline to Week 4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)</measure>
    <time_frame>11 weeks</time_frame>
    <description>Assessing the safety and tolerability of B244 by monitoring the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">547</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>B244 Suspension O.D. 5.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B244 Suspension O.D. 20.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Third arm of 192 subjects will receive a vehicle dosing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>B244</intervention_name>
    <description>B244 suspension</description>
    <arm_group_label>B244 Suspension O.D. 20.0</arm_group_label>
    <arm_group_label>B244 Suspension O.D. 5.0</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle suspension</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects 18 to 65 years of age.&#xD;
&#xD;
          2. Pruritus of at least 4 weeks duration prior to the initial Screening visit and during&#xD;
             the 2 week washout period.&#xD;
&#xD;
             a. Subjects using stable doses of oral H1 antihistamines at the initial Screening&#xD;
             visit must be willing to continue these at the same doses and frequencies throughout&#xD;
             the study inclusive of the follow-up period.&#xD;
&#xD;
          3. Worst Itch Numeric Rating Scale (WI-NRS) score ≥ 7 in the 24-hour period prior to the&#xD;
             initial Screening as well as Baseline visits.&#xD;
&#xD;
          4. Average weekly WI-NRS score ≥6 for each week of the washout period, as recorded in the&#xD;
             eDiary.&#xD;
&#xD;
          5. A history of atopic dermatitis for greater than 12 months consistent with a diagnosis&#xD;
             of atopic dermatitis, as defined by the 2014 American Academy of Dermatology (AAD)&#xD;
             Guidelines of Care for the Management of Atopic Dermatitis.&#xD;
&#xD;
               1. Subjects using bland emollients at the initial Screening visit will be allowed to&#xD;
                  continue to use their emollient of choice at the same dose and frequency&#xD;
                  throughout the study.&#xD;
&#xD;
               2. Subjects using low- to mid-potency topical corticosteroids at the initial&#xD;
                  Screening visit will be allowed to use their topical corticosteroid of choice at&#xD;
                  the same dose and frequency no more than 7 days per month throughout the study as&#xD;
                  rescue medication.&#xD;
&#xD;
          6. A minimum of 10% and not more than 40% of the subjects' BSA affected by atopic&#xD;
             dermatitis (affected is defined by physical examination findings: erythema, edema,&#xD;
             scaling, lichenification, excoriation, with the excoriation serving as the physical&#xD;
             examination correlate of pruritus) at Screening and Baseline.&#xD;
&#xD;
             a. Subjects' BSA can include face and body OR body alone BUT NOT face alone.&#xD;
&#xD;
          7. An Investigator Global Assessment (IGA) score of 2-3 at Screening and Baseline.&#xD;
&#xD;
          8. Willing and able to complete once-daily eDiary entries within a consistent timeframe&#xD;
             for the duration of the study and have ≥80% eDiary compliance rate during the washout&#xD;
             period.&#xD;
&#xD;
          9. Judged to be in good health in the investigator's opinion.,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clearly defined etiology for pruritus other than atopic dermatitis. These include but&#xD;
             are not limited to urticaria, psoriasis or other non-atopic dermatologic conditions,&#xD;
             hepatic or renal disease, psychogenic pruritus, drug reaction, untreated&#xD;
             hyperthyroidism, parasite presence and presence of acute infection either systemically&#xD;
             or in the AD lesions.&#xD;
&#xD;
          2. Presence of any acute condition which may risk inducing an atopic dermatitis flare&#xD;
             during the course of the study, such as impetigo or active herpes simplex infection.&#xD;
&#xD;
          3. Treatment with systemic corticosteroids within 4 weeks prior to randomization.&#xD;
&#xD;
          4. Treatment with Class III or higher potency topical corticosteroids or any topical&#xD;
             anti-pruritic therapies (other than stable doses of low- or mid-potency topical&#xD;
             corticosteroids or bland emollients) within 4 weeks prior to randomization.&#xD;
&#xD;
          5. Treatment with systemic therapies with recognized anti-pruritic (e.g. tricyclic&#xD;
             antidepressants, sedatives, tranquilizers, gabapentin, marijuana or other&#xD;
             cannabinoids, opioid receptor agonists/antagonists) or pruritic (e.g. opioids,&#xD;
             angiotensin-converting enzyme inhibitors, cocaine,,antimalarials) properties within 4&#xD;
             weeks prior to randomization.&#xD;
&#xD;
             a. Stable doses of H1 antihistamines will be permitted. Subjects must be willing to&#xD;
             continue these at the same doses and frequencies throughout the study inclusive of the&#xD;
             follow-up period.&#xD;
&#xD;
          6. Any clinically significant changes in type, dose, or frequency of bland emollients,&#xD;
             low- or mid-potency corticosteroids, and/or oral H1 antihistamines throughout the&#xD;
             study from screening to follow-up.&#xD;
&#xD;
          7. Treatment with systemic immunosuppressive/ immunomodulatory therapies within 4 weeks&#xD;
             prior to randomization (including but not limited to phosphodiesterase-4 inhibitors,&#xD;
             cyclosporine, mycophenolate-mofetil, methotrexate, azathioprine, interferon-gamma, or&#xD;
             phototherapy).&#xD;
&#xD;
          8. Treatment with biologic therapies within 12 weeks or 5 half-lives prior to&#xD;
             randomization, whichever is longer.&#xD;
&#xD;
          9. Use of an indoor tanning facility within 4 weeks prior to randomization.&#xD;
&#xD;
         10. Treatment with any investigational therapy within 4 weeks prior to randomization.&#xD;
&#xD;
         11. Allergen immunotherapy within 6 months prior to randomization.&#xD;
&#xD;
         12. Prior use of AO+ Mist.&#xD;
&#xD;
         13. History of malignancy within 5 years prior to randomization, with the exception of&#xD;
             completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma&#xD;
             of the skin.&#xD;
&#xD;
         14. History of a major psychiatric condition (including major depressive disorder, bipolar&#xD;
             disorder, or schizophrenia), suicidal ideation, or suicide attempt.&#xD;
&#xD;
         15. Known active hepatitis infection.&#xD;
&#xD;
         16. Known history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
         17. Presence of any medical condition or disability that, in the investigator's opinion,&#xD;
             could interfere with the assessment of safety or efficacy in this trial or compromise&#xD;
             the safety of the subject.&#xD;
&#xD;
         18. Currently pregnant or breastfeeding, or male subject with a pregnant or breastfeeding&#xD;
             partner.&#xD;
&#xD;
         19. Females of childbearing potential who are unable or unwilling to practice highly&#xD;
             effective contraception (pregnancy prevention); fertile males who are unable or&#xD;
             unwilling to use condoms with female partners of childbearing potential.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyun Kim, PhD</last_name>
    <role>Study Director</role>
    <affiliation>AOBiome LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cahaba Dermatology</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognitive Clinical Trials</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Trial Associates</name>
      <address>
        <city>Bryant</city>
        <state>Arkansas</state>
        <zip>72022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Applied Research Center of Arkansas, Inc</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Healthcare Group</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encino Research Center</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Dermatology, INC</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antelope Valley Clinical Trials</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Clinical Trials Services</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L.A. Universal Research Center Inc</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Clinical Research</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syrentis Clinical Research</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMMUNOe Research Centers</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Bay Medical Research</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian International Research</name>
      <address>
        <city>Miami Gardens</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Coast Research Center, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>D&amp;H National Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NAPA Research</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Trials of Florida, Inc</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moore Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sneeze Wheeze &amp; Itch Associates, LLC</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epiphany Dermatology</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Continental Clinical Solutions</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakland Hills Dermatology</name>
      <address>
        <city>Auburn Hills</city>
        <state>Michigan</state>
        <zip>48326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarkston Dermatology</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onyx Clinical Reserach</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>mediSearch Clinical Trials</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JDR Dermatology Research, LLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dermatology Group, P. C.</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <zip>07044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials Brooklyn</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials America</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saddick Research Group</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Consulting Services, LLC</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Clinical Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crisor LLC C/O Clinical Research Institute of Southern Oregon, Inc</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermdox Centers for Dematology</name>
      <address>
        <city>Sugarloaf</city>
        <state>Pennsylvania</state>
        <zip>18249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peak Research LLC</name>
      <address>
        <city>Upper Saint Clair</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Providence Clinical Research</name>
      <address>
        <city>Cranston</city>
        <state>Rhode Island</state>
        <zip>02920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AAPRI Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology &amp; Laser Center of Charleston</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions</name>
      <address>
        <city>Milan</city>
        <state>Tennessee</state>
        <zip>38358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACRC Trials</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Dermatology</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dominion Medical Associates</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <disposition_first_submitted>October 7, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>October 7, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 14, 2022</disposition_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04490109
org study id: PRB244-01
nct id: NCT04490109
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety,
      and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of
      atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1
      ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle
      (placebo) for 4 weeks.
This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II
      Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle
      applications on treatment of mild to moderate pruritus associated with atopic dermatitis.

        -  Approximately 576 subjects may be enrolled.

        -  The total duration of the study will be approximately 11 weeks. Participants will report
           for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go
           through a two-week washout phase before reporting for a Baseline visit.

        -  After screening and baseline, participants will be randomized to one of two doses of
           B244 or vehicle application for 4 weeks.

        -  Randomization will be 1:1:1 so that an equal number of patients will be treated in each
           Arm of the study.

        -  All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0

        -  Subjects must be willing and able to complete diary within a consistent time frame on a
           daily basis and to comply with restrictions on allowable therapies for the duration of
           the study.

        -  All subjects will attend a screening visit not more than 21 days prior to Baseline (Day
           0).

        -  Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day
           28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4
           weeks (28 (±3) days) after the last dose of study medication.

        -  Subjects will apply a total of 10 pumps of IP per application across all affected areas
           twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks.

        -  Safety evaluations will consist of review of participant's medical history at screening
           and on-going assessment of adverse events reported throughout the study duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind, randomized, vehicle-controlled, randomized in a 1:1:1 ratio
measure: Mean change in WI-NRS from baseline to Week 4
time frame: 4 weeks
description: Assessing the efficacy of B244 by measuring the mean change in WI-NRS reported by subjects from baseline to Week 4
measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
time frame: 11 weeks
description: Assessing the safety and tolerability of B244 by monitoring the incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
arm group label: B244 Suspension O.D. 5.0
arm group type: Experimental
description: One arm of 192 Subjects will be receiving a dose of B244 O.D. 5.0 suspension
arm group label: B244 Suspension O.D. 20.0
arm group type: Experimental
description: Second arm of 192 subjects will receive a dose of B244 O.D. 20.0 suspension
arm group label: Placebo
arm group type: Placebo Comparator
description: Third arm of 192 subjects will receive a vehicle dosing.
intervention type: Biological
intervention name: B244
description: B244 suspension
arm group label: B244 Suspension O.D. 20.0
arm group label: B244 Suspension O.D. 5.0
intervention type: Biological
intervention name: Vehicle
description: Vehicle suspension
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hyun Kim, PhD
role: Study Director
affiliation: AOBiome LLC
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country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Pruritus
sharing ipd: No