Clinical trial NCT01986933: A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Official title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12
timeFrame: baseline to Week 12
Secondary outcomes:
measure: Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)
timeFrame: baseline to Week 12 (Part A)
measure: Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)
timeFrame: baseline to Week 12 (Part A), up to Week 64 (Part B)
measure: Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)
timeFrame: baseline to Week 12 (Part A)
measure: Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)
timeFrame: baseline to Week 12 (Part A), up to Week 64 (Part B)
measure: Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)
timeFrame: baseline to Week 12 (Part A)
measure: Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)
timeFrame: baseline to Week 12 (Part A), up to Week 64 (Part B)
measure: Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)
timeFrame: baseline to Week 12 (Part A)
measure: Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)
timeFrame: baseline to Week 12 (Part A), up to Week 64 (Part B)
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Bay City
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: College Station
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Chugai Pharmaceutical
name: Ryosuke Mihara
role: STUDY_DIRECTOR
References:
citation: Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10.
citation: Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490.