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
- Conditions
- Atopic dermatitisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-002470-46-GB
- Lead Sponsor
- Chugai Pharmaceutical Co. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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 <4 weeks in duration (e.g. clobetasol propionate) should be applied to the maximum allowed consecutive treatment period which may be <4 consecutive weeks.
b. Patients must have a history of intolerance to, or inability to receive, standard topical therapy (e.g. contraindication). Intolerance is defined as discontinuation due to allergy to TCS and/or TCI.
Note: criteria c and d should only be assessed in patients who meet criteria a or b:
c. EASI =10.
d. Pruritus VAS =50 mm.
5. Patients must meet the following criteria at randomization:
a. Pruritus VAS =50 mm (last 3 consecutive days of the run-in period).
b. EASI =10.
c. sIGA score =3.
6. Both male and female patients of childbearing potential must agree for the duration of the study and for a period of 120 days after administration of the last dose of study drug to the consistent and correct use of an acceptable method of birth control (i.e. methods of birth control which result in a low failure rate [<1% per year] when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or surgically sterilized partner).
Inclusion Criteria (Part B only)
1. Patients who have completed the treatment period for Part A.
2. Patients who are willing to participate in Part B and are able to give written informed consent and comply with the requirements of the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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) <3000 cells/µL, or any other medical condition that, in the opinion of the Investigator, would contraindicate the use of an investigational drug.
3. Clinically significant electrocardiogram (ECG) abnormalities.
4. History of drug dependence or alcohol abuse.
5. Serological evidence of hepatitis B virus (hepatitis B surface antigen positive or hepatitis B core antibody positive) or hepatitis C virus (HCV) (anti-HCV antibody positive) infection (active or past infection). Testing prior to the study is mandatory.
6. Known human immunodeficiency virus (HIV) infection.
7. History of hypersensitivity, including anaphylaxis to an immunoglobulin product (plasma derived or recombinant, e.g. monoclonal antibody).
8. History of skin malignancy. Patients with a history of any other malignancy, who have been in remission for =5 years prior to randomization, or patients with a history of curatively treated in situ carcinoma of the cervix at any time prior to randomization, are eligible.
9. Active dermatological disease other than AD, which is being treated separately.
10. Eye disease requiring systemic treatment.
11. Ongoing treatment with specific or non-specific hyposensitization therapy for AD.
12. Treatment with systemic steroids, immunosuppressant agents or ultraviolet radiation therapy within 4 weeks prior to randomization.
13. Treatment with potent or very potent TCS within 2 weeks prior to randomization.
14. Treatment with mild or moderately potent TCS within 1 week prior to randomization.
15. Patients who have been receiving treatment for asthma within 1 year prior to randomization or who had previously been diagnosed with asthma and experienced asthmatic symptoms (including, but not limited to, wheezing, shortness of breath, cough after exercise) within 1 year prior to randomization.
16. Treated with TCI or vitamin D (including activated vitamin D) within 2 weeks prior to randomization.
17. Treated with an antihistamine (topical or systemic) within 1 week prior to randomization.
18. Treatment with a hypnotic within 1 week prior to randomization.
19. Treatment with any other therapy for AD and pruritus, including emollients (e.g. Atopiclair®, MimyX™) approved or cleared by FDA as devices, within 4 days prior to randomization.
20. History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
21. Treatment with any investigational agent including placebo within 16 weeks prior to randomization.
22. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br>;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.<br>2) To evaluate the long-term efficacy profile of CIM331 (Part B).
- Secondary Outcome Measures
Name Time Method