Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type Psoriasis
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Celgene
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Inclusion Criteria
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.
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
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).
+7 more
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: CC-90006; Dose level 4Experimental Treatment1 Intervention
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Group II: CC-90006; Dose level 3Experimental Treatment1 Intervention
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Group III: CC-90006; Dose level 2Experimental Treatment1 Intervention
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Group IV: CC-90006; Dose level 1Experimental Treatment1 Intervention
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Group V: PlaceboPlacebo Group1 Intervention
Placebo (saline) will be administered subcutaneously (SC) on days 1, 15, and 29.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Altoona Center for Clinical ResearchDuncansville, PA
Anaheim Clinical Trials, LLCAnaheim, CA
TKL ResearchFair Lawn, NJ
Innovaderm ResearchMontreal, Canada
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Who Is Running the Clinical Trial?
CelgeneLead Sponsor