xml: <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/NCT06037148</url>
    </required_header>
    <id_info>
      <org_study_id>DM-101-C-002</org_study_id>
      <nct_id>NCT06037148</nct_id>
    </id_info>
    <brief_title>Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants</brief_title>
    <official_title>A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Desentum Oy</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Desentum Oy</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate&#xD;
        safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen&#xD;
        allergic adults. As an explorative objective, the trial will also investigate the effect of&#xD;
        DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber.&#xD;
        Expanded access to the study treatment is not available.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be carried out in a single study site located in Canada&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 7, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double (Participant, Investigator)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment Emergent Adverse Events</measure>
      <time_frame>From the first dose to until 14-28 days from the last dose</time_frame>
      <description>Occurrence of treatment emergent adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse Events of Special Interest</measure>
      <time_frame>From the first dose to until 14-28 days from the last dose</time_frame>
      <description>Occurrence of local injection site reactions and systemic allergic reactions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subjects Reaching the Maximum Intended Dose</measure>
      <time_frame>Through the treatment period, an average of 10 weeks</time_frame>
      <description>Number of subjects in each cohort who reach the maximum intended dose</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Birch Pollen Allergy</condition>
    <arm_group>
      <arm_group_label>DM-101PX low dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 subcutaneous doses starting from 0.05 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DM-101PX middle dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 subcutaneous doses starting from 0.1 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DM-101PX high dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 subcutaneous doses starting from 0.2 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>DM-101PX</intervention_name>
      <description>subcutaneous injection of DM-101PX</description>
      <arm_group_label>DM-101PX high dose</arm_group_label>
      <arm_group_label>DM-101PX low dose</arm_group_label>
      <arm_group_label>DM-101PX middle dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo to Match DM-101PX</intervention_name>
      <description>Placebo to match DM-101PX administered subcutaneously</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Either sex or any race, aged 18 to 65 years&#xD;
  &#xD;
            -  Good general health&#xD;
  &#xD;
            -  A documented clinical history of moderate to severe birch pollen induced allergic&#xD;
               rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or&#xD;
               sleep and remain bothersome despite the use of relevant symptomatic medication, and&#xD;
               have been present over at least 2 previous birch pollen seasons&#xD;
  &#xD;
            -  Birch pollen specific IgE ≥ 0.7 kU/L&#xD;
  &#xD;
            -  Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm&#xD;
  &#xD;
            -  Body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History or findings on physical examination of any significant disease or disorder&#xD;
               which, in the opinion of the Investigator, could put the subject at risk because of&#xD;
               participation in the trial, influence the results of the trial or subject's ability to&#xD;
               participate in the trial&#xD;
  &#xD;
            -  Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA&#xD;
               Step 2 or higher treatment, or asthma partially controlled or uncontrolled according&#xD;
               to GINA classification in the 6 months before screening&#xD;
  &#xD;
            -  Significant rhinitis, sinusitis, significant and/or severe allergies not associated&#xD;
               with the birch pollen season&#xD;
  &#xD;
            -  History of asthma deterioration that resulted in emergency treatment or&#xD;
               hospitalization in the past 12 months before screening, or a life-threatening asthma&#xD;
               attack at any time in the past&#xD;
  &#xD;
            -  A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value&#xD;
  &#xD;
            -  History of severe drug allergy, severe angioedema, or systemic allergic reaction of&#xD;
               Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any&#xD;
               cause&#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>Anna Nilson</last_name>
      <role>Study Director</role>
      <affiliation>Desentum Oy</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Patricia Couroux</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cliantha Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anna Nilson</last_name>
      <phone>+358503106846</phone>
      <email>anna.nilson@desentum.fi</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cliantha Research</name>
        <address>
          <city>Mississauga</city>
          <state>Ontario</state>
          <zip>ON L4W 1A4</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patricia Couroux</last_name>
        <phone>905-282-1808</phone>
        <phone_ext>2308</phone_ext>
        <email>pcouroux@cliantha.com</email>
      </contact>
      <contact_backup>
        <last_name>Radu Nanau</last_name>
        <phone>905-282-1808</phone>
        <phone_ext>2415</phone_ext>
        <email>rnanau@cliantha.com</email>
      </contact_backup>
      <investigator>
        <last_name>Patricia Couroux, MD, FRCPC</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Rhinitis, Allergic, Seasonal</mesh_term>
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All individual participant data that underlie publicly available results will be considered for sharing</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
      <ipd_access_criteria>Qualified researchers may request access to patient level data and related study documents: patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants after Desentum has received marketing authorization from major health authorities (e.g. FDA, EMA), has the legal authority to share the data, and has made the study results publicly available.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037148
  org study id: DM-101-C-002
  nct id: NCT06037148
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate
        safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen
        allergic adults. As an explorative objective, the trial will also investigate the effect of
        DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber.
        Expanded access to the study treatment is not available.
  The study will be carried out in a single study site located in Canada
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: 3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
  primary purpose: Other
  masking: Double (Participant, Investigator)
  masking description: Double (Participant, Investigator)
  measure: Treatment Emergent Adverse Events
  time frame: From the first dose to until 14-28 days from the last dose
  description: Occurrence of treatment emergent adverse events
  measure: Adverse Events of Special Interest
  time frame: From the first dose to until 14-28 days from the last dose
  description: Occurrence of local injection site reactions and systemic allergic reactions
  measure: Subjects Reaching the Maximum Intended Dose
  time frame: Through the treatment period, an average of 10 weeks
  description: Number of subjects in each cohort who reach the maximum intended dose
  arm group label: DM-101PX low dose
  arm group type: Experimental
  description: 10 subcutaneous doses starting from 0.05 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
  arm group label: DM-101PX middle dose
  arm group type: Experimental
  description: 10 subcutaneous doses starting from 0.1 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
  arm group label: DM-101PX high dose
  arm group type: Experimental
  description: 10 subcutaneous doses starting from 0.2 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
  intervention type: Biological
  intervention name: DM-101PX
  description: subcutaneous injection of DM-101PX
  arm group label: DM-101PX high dose
  arm group label: DM-101PX low dose
  arm group label: DM-101PX middle dose
  intervention type: Biological
  intervention name: Placebo to Match DM-101PX
  description: Placebo to match DM-101PX administered subcutaneously
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Anna Nilson
  role: Study Director
  affiliation: Desentum Oy
  last name: Patricia Couroux
  role: Principal Investigator
  affiliation: Cliantha Research
  last name: Anna Nilson
  phone: +358503106846
  email: anna.nilson@desentum.fi
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Rhinitis, Allergic, Seasonal
  mesh term: Hypersensitivity
  sharing ipd: Yes
  ipd description: All individual participant data that underlie publicly available results will be considered for sharing
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
  ipd access criteria: Qualified researchers may request access to patient level data and related study documents: patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants after Desentum has received marketing authorization from major health authorities (e.g. FDA, EMA), has the legal authority to share the data, and has made the study results publicly available.