Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

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: NCT03985943
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
Safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis

Condition or disease Intervention/treatment Phase
Moderate-to-Severe Atopic Dermatitis Drug: Placebo Drug: Nemolizumab Phase 3

Detailed Description:
Assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Experimental: Nemolizumab
Nemolizumab Active
Drug: Nemolizumab
Nemolizumab
Other Name: CD14152




Primary Outcome Measures :
  1. Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction [ Time Frame: Baseline to Week 16 ]
  2. Proportion of subjects with EASI-75 [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 16 ]
  2. Proportion of subjects with PP NRS < 2 [ Time Frame: Week 16 ]
  3. Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4 [ Time Frame: Week 16 ]
  4. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 4 ]
  5. Proportion of subjects with PP NRS < 2 [ Time Frame: Week 4 ]
  6. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 2 ]
  7. Proportion of subjects with an improvement of PP NRS ≥ 4 [ Time Frame: Week 1 ]
  8. Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4 [ Time Frame: Week 16 ]
  9. Proportion of subjects with IGA success and improvement of PP NRS ≥ 4 [ Time Frame: Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female subjects aged ≥ 12 years at the screening visit

    Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who will then determine the eligibility of this age group for enrollment in the study.

  2. Chronic AD that has been documented for at least 2 years
  3. EASI score ≥ 16
  4. IGA score ≥ 3
  5. AD involvement ≥ 10% of BSA
  6. Documented recent history of inadequate response to topical medications (TCS with or without TCI).
  7. Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection, 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:

  1. Body weight < 30 kg.
  2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
  3. Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
  4. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
  5. 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): NCT03985943


Contacts
Layout table for location contacts
Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com
Contact: Etter Sr. Project Manager 817-961-5000 clinical.studies@galderma.com

  Show 90 Study Locations
Sponsors and Collaborators
Galderma R&D

Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03985943     History of Changes
Other Study ID Numbers: RD.06.SPR.118161
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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