A Phase 1 interventional study of CC-90006 and Placebo in Psoriasis, sponsored by Celgene. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-05-07.
Sponsored by Celgene · Phase 1, Interventional, and Treatment
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.
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).
The following is a summary of the 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.
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.
Exclusion Criteria:
The following is a summary of the exclusion criteria:
Presence of a systemic infection or any potentially opportunistic infections (eg, atypical mycobacterial, CMV, Clostridium difficile, multifocal herpetic, etc).
(Immunologic disorders such as rheumatoid arthritis, lupus, asthma, and any immunodeficiency are exclusionary.)
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Drug: CC-90006
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Drug: CC-90006
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Drug: CC-90006
CC-90006 will be administered subcutaneously (SC) on days 1, 15, and 29.
Drug: CC-90006
Placebo (saline) will be administered subcutaneously (SC) on days 1, 15, and 29.
Other: Placebo
CC-90006
Placebo
Adverse Events (AEs)
Number of participants with adverse events
Time frame: Up to approximately Week 20
Pharmacokinetics: Cmax
Observed maximum concentration of CC-90006 in serum
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Tmax
Time to reach the observed maximum concentration of CC-90006 in serum
Time frame: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-t
Area under that serum-concentration time curve calculated from time zero to the last measured time point
Time frame: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-∞
Area under that serum-concentration time curve calculated from time zero to ∞
Time frame: Up to approximately 16 weeks
Pharmacokinetics - t1/2
Terminal elimination half-life
Time frame: Up to approximately 16 weeks
Pharmacokinetics - CL/F
Apparent clearance of drug from serum after extravascular administration
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Vz/F
Apparent volume of distribution during the terminal phase
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Rac [AUCτ]
Accumulation ratio based on Cmax (Rac \[Cmax\]) and AUCτ
Time frame: Up to approximately 16 weeks
Fraction of subjects with Anti-drug antibody (ADA)
Measure of the body's immune response to CC-90006
Time frame: Up to approximately 16 weeks
Plan to share: No
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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