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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03921411
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
Asses the pharmacokinetics and safety of nemolizumab in adolescent subjects with AD.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Nemolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Nemolizumab
Nemolizumab
Biological: Nemolizumab
Nemolizumab




Primary Outcome Measures :
  1. Nemolizumab serum concentration in adolescent subjects [ Time Frame: Baseline to Week 24 ]
  2. Incidence of adverse events, including TEAEs, AESIs and SAEs [ Time Frame: Baseline to Week 24 ]
  3. 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

  4. 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

  5. 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 ]
  6. Number of subjects who have a clinically significant abnormal ECG [ Time Frame: Screening to Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921411


Contacts
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Contact: Galderma 817-961-5000 clinical.studies@galderma.com

Locations
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United States, California
Galderma Investigational Site Recruiting
Fountain Valley, California, United States, 92708
Galderma Investigational Site Recruiting
Fremont, California, United States, 94538
United States, Florida
Galderma Investigational Site Not yet recruiting
Jacksonville, Florida, United States, 32256
Galderma Investigational Site Recruiting
Tampa, Florida, United States, 33607
United States, Georgia
Galderma Investigational Site Recruiting
Columbus, Georgia, United States, 31904
Galderma Investigational Site Recruiting
Sandy Springs, Georgia, United States, 30128
United States, Oregon
Galderma Investigational Site Recruiting
Gresham, Oregon, United States, 97030
United States, Texas
Galderma Investigational Site Suspended
Allen, Texas, United States, 75013
Galderma Investigational Site Recruiting
Dallas, Texas, United States, 75230-5806
Galderma Investigational Site Recruiting
Frisco, Texas, United States, 75034
United States, Virginia
Galderma Investigational Site Recruiting
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Galderma R&D

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03921411     History of Changes
Other Study ID Numbers: RD.06.SPR.116912
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases