Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Galderma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Nemolizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03100344

RD.03.SPR.114322

Details and patient eligibility

About

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.

Full description

The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

Nemolizumab (low dose)

Treatment:

Drug: Nemolizumab

Group 2

Experimental group

Description:

Nemolizumab (medium dose)

Treatment:

Drug: Nemolizumab

Group 3

Experimental group

Description:

Nemolizumab (high dose)

Treatment:

Drug: Nemolizumab

Group 4

Placebo Comparator group

Description:

Nemolizumab placebo

Treatment:

Drug: Placebo