A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Chugai Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Other: Placebo; Drug: nemolizumab (CIM331)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01986933

CIM003JG

Details and patient eligibility

About

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Enrollment: 264 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 and ≤65 years of age at the time of consent.
• Patients with Atopic Dermatitis
• Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
• Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
• static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Exclusion criteria

• Serological evidence of hepatitis B virus or hepatitis C virus infection
• Known human immunodeficiency virus infection
• Ongoing treatment with specific or non-specific hyposensitization therapy for AD
• Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
• History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
• Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
• Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 5 patient groups

Group1

Experimental group

Description:

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Treatment:

Drug: nemolizumab (CIM331)

Group2

Experimental group

Description:

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Treatment:

Drug: nemolizumab (CIM331)

Group3

Experimental group

Description:

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Treatment:

Drug: nemolizumab (CIM331)

Group4

Experimental group

Description:

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Treatment:

Drug: nemolizumab (CIM331)

Group5

Experimental group

Description:

Part A: Placebo Part B: nemolizumab (CIM331)

Treatment:

Drug: nemolizumab (CIM331)

Other: Placebo