Psoriasis
Conditions
Keywords
Psoriasis, CC-90006, Mild to moderate plaque-type psoriasis, Safety, Pharmacokinetics, Pharmacodynamics
Brief summary
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.
Detailed description
The study will be conducted in subjects with mild to moderate plaque-type psoriasis. The study will consist of escalating multiple (three) doses in sequential groups. Approximately 40 subjects with plaque-type psoriasis will be enrolled into approximately 4 planned dose cohorts. Each cohort will study a different CC-90006 dose level and have ten subjects; eight subjects will receive CC-90006 and two subjects will receive placebo. Subjects will be dosed according to a computer-generated randomization scheme. Dosing will occur on Days 1, 15 (Week 2), and 29 (Week 4). During the study, blood samples and punch biopsies will be collected to determine the amount of CC-90006 in the body and to evaluate its effect on the subject's condition. Subjects will return to the clinic for regular follow up visits for safety, PK, and PD. A follow up phone call to each subject to determine general health will occur on Day 141 (week 20).
Interventions
DRUGCC-90006
CC-90006
OTHERPlacebo
Placebo
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
The following is a summary of the inclusion criteria: 1. Males or non-pregnant females between the ages of 18 and 60 years (inclusive) at the time of signing the ICF, and be willing to adhere to the requirements of contraception use throughout the study. 1. Female subjects who claim to be surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy; proper documentation required) must have undergone the procedure at least 6 months before screening, 2. Females who claim to be postmenopausal (defined as 24 consecutive months without menses before screening, should have a confirmed follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening). 3. All other females must: i. Have two negative pregnancy tests (at screening and baseline) as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. ii. Either commit to true abstinence from heterosexual contact or agree to use two forms of reliable contraception simultaneously. One must be a highly effective method and one additional effective (barrier) method, and both must be practiced without interruption, 28 days prior to starting investigational product, during the study therapy (including dose interruptions), and for 4 months after discontinuation of study therapy. d. Males must practice true abstinence1 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms are recommended\]) during sexual contact with a pregnant female or FCBP2 while participating in the study, during dose interruptions, and for at least 4 months after the last dose of IP, even if he has undergone a successful vasectomy. 2. Must be diagnosed with mild to moderate plaque-type psoriasis at least 6 months prior to baseline (Day 1). 3. Must have a PASI ≤ 15 at screening and baseline (Day 1). 4. Must have a body surface area affected score (BSA) ≥ 1 and sPGA ≥ 3 at screening and baseline (Day 1). 5. Must have at least two plaques, at least 3 x 3 centimeters(cm) in diameter. One plaque will be used for punch biopsy and the other for TPSS evaluation. 6. Other than the diagnosed condition of mild to moderate plaque-type psoriasis, the subject must be in good health as determined by a physical examination (PE) at screening. 7. Has a body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening. 8. For all other clinical laboratory safety test parameters, the subject has results within normal limits or judged to be not clinically significant by the Investigator.
Exclusion criteria
The following is a summary of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to approximately Week 20 | Number of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - Tmax | Up to approximately 16 weeks | Time to reach the observed maximum concentration of CC-90006 in serum |
| Pharmacokinetics - AUC 0-t | Up to approximately 16 weeks | Area under that serum-concentration time curve calculated from time zero to the last measured time point |
| Pharmacokinetics - AUC 0-∞ | Up to approximately 16 weeks | Area under that serum-concentration time curve calculated from time zero to ∞ |
| Pharmacokinetics - t1/2 | Up to approximately 16 weeks | Terminal elimination half-life |
| Pharmacokinetics: Cmax | Up to approximately 16 weeks | Observed maximum concentration of CC-90006 in serum |
| Pharmacokinetics - Vz/F | Up to approximately 16 weeks | Apparent volume of distribution during the terminal phase |
| Pharmacokinetics - Rac [AUCτ] | Up to approximately 16 weeks | Accumulation ratio based on Cmax (Rac \[Cmax\]) and AUCτ |
| Fraction of subjects with Anti-drug antibody (ADA) | Up to approximately 16 weeks | Measure of the body's immune response to CC-90006 |
| Pharmacokinetics - CL/F | Up to approximately 16 weeks | Apparent clearance of drug from serum after extravascular administration |
Countries
Canada, United States
Outcome results
None listed