Phase 2
Completed N=264
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Source: ClinicalTrials.gov NCT01986933 ↗Enrolled (actual)
264
Serious AEs
6.1%
Results posted
Nov 2021
Primary outcomePrimary: Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 — -20.07; -41.46; -61.24; -60.46 percentage change — p=0.0027
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 |
-20.07; -41.46; -61.24; -60.46 | 0.0027 sig |
| SECONDARY Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) |
-12.12; -26.89; -35.70; -33.86; -21.82; -25.17 | — |
| SECONDARY Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) |
-25.47; -32.11; -32.48; -25.43; -25.13; -47.86 | — |
| SECONDARY Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) |
-6.83; -29.31; -34.59; -29.82; -17.29; -26.41 | — |
| SECONDARY Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) |
-27.73; -30.30; -28.20; -25.31; -29.05; -36.16 | — |
| SECONDARY Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) |
-0.2; -0.8; -0.9; -0.6; -0.5; -0.7 | — |
| SECONDARY Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) |
-0.7; -0.8; -0.6; -0.4; -0.8; -1.0 | — |
| SECONDARY Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) |
-7.48; -12.11; -23.49; -18.44; -14.44; -14.90 | — |
| SECONDARY Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) |
-10.12; -23.28; -17.98; -2.79; -18.08; -29.58 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01986933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.