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A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Subjects With Atopic Dermatitis (AD)

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ClinicalTrials.gov Identifier: NCT03921411
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE April 9, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Nemolizumab serum concentration in adolescent subjects [ Time Frame: Baseline to Week 24 ]
  • Incidence of adverse events, including TEAEs, AESIs and SAEs [ Time Frame: Baseline to Week 24 ]
  • Number of subjects who have a change from baseline in physical examinations (normal to abnormal) at each visit [ Time Frame: Baseline to Week 24 ]
    A complete physical exam includes:
    • Head, ears, eyes, nose, throat, neck (including thyroid)
    • Skin/integumentary system
    • Cardiovascular system
    • Respiratory system
    • Gastrointestinal system
    • Musculoskeletal system
    • Lymph nodes
    • Nervous system
    • Respiratory exam
  • Number of subjects who have a change from baseline in vital signs (normal to abnormal) at each visit [ Time Frame: Baseline to Week 24 ]
    Vital signs includes:
    • Systolic Blood Pressure
    • Diastolic Blood Pressure
    • Pulse Rate
    • Temperature
  • Number of subjects who have clinically significant laboratory abnormalities in hematology, blood chemistry, or urinalysis results at each visit [ Time Frame: Baseline to Week 24 ]
  • Number of subjects who have a clinically significant abnormal ECG [ Time Frame: Screening to Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03921411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Subjects With Atopic Dermatitis (AD)
Official Title  ICMJE A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis
Brief Summary Asses the pharmacokinetics and safety of nemolizumab in adolescent subjects with AD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Biological: Nemolizumab
Nemolizumab
Study Arms  ICMJE Experimental: Nemolizumab
Nemolizumab
Intervention: Biological: Nemolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  • Male or female subjects ≥ 12 to < 18 years of age
  • Chronic AD that has been documented for at least 2 years
  • Eczema Area and Severity Index (EASI) score ≥ 16
  • IGA score ≥ 3
  • AD involvement ≥ 10% of Body Surface Area (BSA)
  • Documented recent history of inadequate response to topical medications
  • Women of childbearing potential must agree to be strictly abstinent or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria

  • Body weight < 30 kg
  • Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
  • History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
  • Any clinically significant issue, based investigator judgement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galderma 817-961-5000 clinical.studies@galderma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921411
Other Study ID Numbers  ICMJE RD.06.SPR.116912
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galderma R&D
Study Sponsor  ICMJE Galderma R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma R&D
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP