A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis
- Registration Number
- NCT03971825
- Lead Sponsor
- Celgene
- Brief Summary
This is a phase 1, randomized, single-center, 3-part, study to assess the safety, tolerability, PK, and PD, of single and multiple doses of CC-92252 in healthy adult subjects and multiple doses of CC-92252 in adult subjects with psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 131
Subjects must satisfy the following criteria to be enrolled in the study:
Part 1, Part 2, and Part 3
-
Subject is ≥ 18 and ≤ 55 years (Part 1 and Part 2) and age is ≥ 18 and ≤ 60 years (Part 3) of age at the time of signing the ICF.
-
Subject has provided informed consent prior to initiation of any study specific activities/procedures
-
Subject has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2 (Part 1 and Part 2) and BMI ≥ 18 and ≤ 33 kg/m2 (Part 3), at screening.
-
Subject has clinical laboratory safety test results that are within normal limits or considered not clinically significant by the Investigator.
Applicable to Part 3 only
-
Subject has a clinical diagnosis of stable plaque-type PsO at least 6 months prior to screening, defined as:
BSA ≥ 5% (at both screening and baseline), and sPGA score ≥ 3 (at both screening and baseline)
-
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 Target Plaque Severity Score (TPSS) evaluation.
-
Must be in generally good health (except for PsO) as judged by the Investigator
-
No prior exposure to systemic treatments or biologics for the treatment of psoriasis
The presence of any of the following will exclude a subject from enrollment:
Part 1, Part 2, and Part 3
-
Subject has any significant medical condition that would prevent the subject from participating in the study.
a. Part 3 only: This exclusion does not apply to plaque psoriasis
-
History or presence of cancer
-
Presence of pre-cancerous conditions
-
History or presence of a systemic infection or any potentially opportunistic infections
-
Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
-
Subject has any condition that confounds the ability to interpret data from the study
-
Subject is pregnant or breastfeeding
-
Part 1 and Part 2 only: Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer)
-
Part 1 and Part 2 only: Subject has used any prescribed systemic or topical medication within 30 days prior to the first dose administration.
-
Part 1 and Part 2 only: Subject has used any non-prescribed systemic or topical medication within 14 days prior to the first dose administration. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to and documented by the Investigator and Sponsor's Medical Monitor.
-
Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs
-
Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen
-
Subject is known to have a history of hepatitis B and/or hepatitis C, or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening Note: Subjects who received hepatitis B vaccination and who test positive for hepatitis B surface antibody and negative for both hepatitis B surface antigen and hepatitis B core antibody remain eligible for study participation
-
Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported)
-
Vaccination within 30 days prior to the first dose administration or subject has plans to receive a vaccination during the course of the study
-
Subject has received immunization with a live or live attenuated vaccine within 2 months prior to the first dose administration or is planning to receive immunization with a live or live attenuated vaccine for 2 months following the last dose administration
-
Subject has a positive QuantiFERON®-TB Gold (or equivalent) TB test at screening or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) TB tests at screening
-
Subject has a history of incompletely treated Mycobacterium tuberculosis (TB) infection
-
Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to first dose administration.
-
Prolonged sun exposure or use of tanning booths Applicable to Part 3 only
-
Presence of non-plaque psoriasis
-
Subject has psoriasis flare within 4 weeks before screening
-
Presence of dermatological diseases other than plaque psoriasis
-
Presence of Psoriatic Arthritis
-
Use of topical therapy for psoriasis within 14 days of first dosing (including but not limited to corticosteroids, retinoids, vitamin D analog, calcineurin inhibitors, salicylic acid) Exceptions: low potency topical corticosteroids will be allowed as background therapy for treatment of psoriatic lesions of the face, axillae and groin in accordance with the manufacturers' suggested usage; subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions; Eucerin® cream (the standard emollient for this study; or equivalent) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to each clinic visit.
-
Use of systemic therapy for psoriasis within 30 days of first dose administration
-
Use of phototherapy for psoriasis within 30 days of first dose administration
-
Use of systemic biologic treatment within 24 weeks of first dose administration
-
Exposure to an immunosuppressive or immunomodulatory drug within 30 days of first dose administration, or five half-lives of the drug (whichever is longer)
-
Exposure to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Administration of CC-92252 and Placebo in Healthy Subjects Placebo Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks. Administration of CC-92252 and Placebo in Psoriasis subjects CC-92252 Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks. Administration of CC-92252 and Placebo in Psoriasis subjects Placebo Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoris will receive CC-92252 or placebo for up to 12 weeks. Administration of CC-92252 and Placebo in Healthy Subjects CC-92252 Part 1 of the study will be conducted as a single ascending dose study, each cohort will consist of 9 subjects. Part 2 of the study will be conducted as a multiple ascending dose study, each cohort will consist of 8 subjects. In part 3, subjects with psoriasis will receive CC-92252 or placebo for up to 12 weeks.
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) From enrollment until at least 28 days after completion of study treatment Number of participants with adverse event
- Secondary Outcome Measures
Name Time Method Pharmacokinetics - t1/2z UP to 16 weeks Terminal elimination half-life
Pharmacokinetics - CL/F Up to 16 weeks Apparent clearance of drug from serum after subcutaneous dosing administration
Anti-drug Antibody Immunogenicity Anti-drug antibody Up to 16 weeks Evaluation of anti-CC-92252 antibody formation
Pharmacokinetics - CL Up to 16 weeks clearance of drug from serum after IV dosing
Pharmacokinetics - Cmax Up to 16 weeks Observed maximum serum concentration
Pharmacokinetics - AUC0-t Up to 16 weeks Area under the serum concentration-time curve calculated from time zero to the last measured time point
Pharmacokinetics - AUC0-∞ Up to 16 weeks The area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration
Pharmacokinetics - Tmax Up to 16 weeks Time to Cmax
Pharmacokinetics - Vz/F Up to 16 weeks Apparent volume of distribution during the terminal phase
Pharmacokinetics - Vz Up to 16 weeks Apparent volume of distribution during the terminal phase
Assessment of Pharmacodynamic biomarkers UP to 24 weeks Change in lymphocyte counts
Trial Locations
- Locations (1)
Charite Research Organisation GmbH
🇩🇪Berlin, Germany