Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

Key facts

Study ID

NCT03100344

Run by

Galderma R&D

People needed

226

Starts

2017-06-14

Expected to finish

2018-09-21

Last updated by the study team

2019-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects ≥ 18 years (or legal age when higher)
• Chronic AD, that has been present for at least 2 years before the visit
• Eczema Area and Severity Index (EASI) score ≥12
• Investigator Global Assessment (IGA) score ≥ 3
• AD involvement ≥ 10% of Body Surface Area (BSA)
• Severe pruritus on at least 3 of the last 7 days before the visit
• Documented recent history (within 6 months before the visit) of inadequate response to topical medications
• Female subjects must fulfill one of the criteria below:
• Female subjects of non-childbearing potential
• Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration

You may not qualify if…

• Body weight < 45 kg
• subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value
• Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
• Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
• History of intolerance to low or mid potency TCS or for whom TCS is not advisable

Where it is running

• Galderma Investigational site — Fort Smith, Arkansas, United States
• Galderma Investigational site — Beverly Hills, California, United States
• Galderma Investigational site — Fountain Valley, California, United States
• Galderma Investigational site — Fremont, California, United States
• Galderma Investigational site — Rolling Hills Estates, California, United States
• Galderma Investigational site — Santa Ana, California, United States
• Galderma Investigational site — Santa Monica, California, United States
• Galderma Investigational site — Miami, Florida, United States
• Galderma Investigational site — Tampa, Florida, United States
• Galderma Investigational Site — Tampa, Florida, United States
• Galderma Investigational site — Columbus, Georgia, United States
• Galderma Investigational site — Sandy Springs, Georgia, United States
• Galderma Investigational Site — Darien, Illinois, United States
• Galderma Investigational Site — Overland Park, Kansas, United States
• Galderma Investigational site — New Orleans, Louisiana, United States
• Galderma Investigational Site — Farmington Hills, Michigan, United States
• Galderma Investigational site — Forest Hills, New York, United States
• Galderma Investigational site — New York, New York, United States
• Galderma Investigational Site — New York, New York, United States
• Galderma Investigational site — Chapel Hill, North Carolina, United States
• Galderma Investigational Site — Johnston, Rhode Island, United States
• Galderma Investigational site — Dallas, Texas, United States
• Galderma Investigational site — San Antonio, Texas, United States
• Galderma Investigational Site — Waco, Texas, United States
• Galderma Investigational site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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