A Phase II repeated dose, randomized and blinded trial of CIM331 in patients with eczema in whom products applied to the skin do not provide sufficient relief or produce side effects

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002470-46-GB

Enrollment

250

Registered

2013-09-25

Start date

2013-12-10

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis

Interventions

Product Name: CIM331 Product Code: CIM331 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: humanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria – Part A Patients must meet the following criteria for study entry: 1. =18 and =65 years of age at the time of consent. 2. Patients must be able to give written informed consent and comply with the requirements of the study protocol. 3. Patients must satisfy the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka. 4. Patients must meet either a or b and c, d at the screening visit (Day -28 to Day -8): a.Patients must have a history of inadequate response (defined as sIGA score =3) to a stable regimen =4* consecutive weeks of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI). Note: TCS must be “potent” or “very potent” according to the classification provided. *Note: A TCS which is restricted for use =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria (Part A and Part B) Patients who meet any of the following criteria will be excluded from study entry: 1. Known significant cardiac disease (New York Heart Association Class III or IV). 2. Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding, including aspartate aminotransferase or alanine aminotransferase >2 x upper limit of normal (ULN), or serum creatinine =2 mg/dL (177 µmol/L), or total white blood cells (WBC) Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) skin test and/or positive interferon-gamma release assay. Such patients may participate in the study if further diagnostic work-up according to local guidelines (including chest X-ray if appropriate) reveals no evidence of latent or active TB. The interferon-gamma release assay sho

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Percent improvement from baseline in pruritus VAS at Week 12 (Part A).;Timepoint(s) of evaluation of this end point: Week 12;Main Objective: 1) To evaluate the dose response profile of CIM331 in the treatment of pruritus as defined by the percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus VAS (Part A). ;Secondary Objective: 1) To further evaluate the efficacy of CIM331 compared with placebo as measured by the EASI, SCORAD, sIGA, BSA of AD involvement, pruritus VAS, pruritus VRS, sleep disturbance VAS, time to rescue therapy, and proportion of patients receiving rescue therapy. 2) To evaluate the long-term efficacy profile of CIM331 (Part B).	—

Measure

Time frame

Primary end point(s): Percent improvement from baseline in pruritus VAS at Week 12 (Part A).;Timepoint(s) of evaluation of this end point: Week 12;Main Objective: 1) To evaluate the dose response profile of CIM331 in the treatment of pruritus as defined by the percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus VAS (Part A). ;Secondary Objective: 1) To further evaluate the efficacy of CIM331 compared with placebo as measured by the EASI, SCORAD, sIGA, BSA of AD involvement, pruritus VAS, pruritus VRS, sleep disturbance VAS, time to rescue therapy, and proportion of patients receiving rescue therapy. 2) To evaluate the long-term efficacy profile of CIM331 (Part B).

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Week 12 and selected time points.;Secondary end point(s): Secondary efficacy outcome measures (Part A and Part B): ? Improvement from baseline in pruritus VAS, EASI, SCORAD, sIGA, Body Surface Area (BSA) of AD involvement, pruritus VRS and sleep disturbance VAS at Week 12 and selected time points. ? EASI: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points. ? SCORAD: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points. ? sIGA: Proportion of patients with a 2 or more point improvement from baseline at Week 12 and selected time points. ? Pruritus VAS: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points. ? Pruritus VRS: proportion of patients with a 2 or more point improvement from baseline at Week 12 and selected time points. ? Time to response of pruritus VAS improvement from baseline 25%, 50%, 75%. ? Time to response of EASI improvement from baseline 25%, 50%, 75%. ? Time to response of SCORAD improvement from baseline 25%, 50%, 75%. ? Time to response of 2 point improvement from baseline of sIGA. ? Time to rescue therapy. ? Proportion of patients receiving rescue therapy.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Week 12 and selected time points.;Secondary end point(s): Secondary efficacy outcome measures (Part A and Part B): ? Improvement from baseline in pruritus VAS, EASI, SCORAD, sIGA, Body Surface Area (BSA) of AD involvement, pruritus VRS and sleep disturbance VAS at Week 12 and selected time points. ? EASI: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points. ? SCORAD: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points. ? sIGA: Proportion of patients with a 2 or more point improvement from baseline at Week 12 and selected time points. ? Pruritus VAS: proportion of patients with 25%, 50%, 75% improvement from baseline at Week 12 and selected time points. ? Pruritus VRS: proportion of patients with a 2 or more point improvement from baseline at Week 12 and selected time points. ? Time to response of pruritus VAS improvement from baseline 25%, 50%, 75%. ? Time to response of EASI improvement from baseline 25%, 50%, 75%. ? Time to response of SCORAD improvement from baseline 25%, 50%, 75%. ? Time to response of 2 point improvement from baseline of sIGA. ? Time to rescue therapy. ? Proportion of patients receiving rescue therapy.

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Countries

Germany, Japan, Poland, United Kingdom, United States

Contacts

Public ContactRegulatory Affairs

Chugai Pharma Marketing Ltd

regulatory@chugai-pharm.co.uk442089875680

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026