A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-92252 and Placebo in Healthy Subjects 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. |
Drug: CC-92252
CC-92252
Other: Placebo
Placebo
|
| Experimental: Administration of CC-92252 and Placebo in Psoriasis subjects 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. |
Drug: CC-92252
CC-92252
Other: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Adverse Events (AEs) [From enrollment until at least 28 days after completion of study treatment]
Number of participants with adverse event
Secondary Outcome Measures
- 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 - 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
- Pharmacokinetics - CL [Up to 16 weeks]
clearance of drug from serum after IV dosing
- 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
- Anti-drug Antibody Immunogenicity Anti-drug antibody [Up to 16 weeks]
Evaluation of anti-CC-92252 antibody formation
- Assessment of Pharmacodynamic biomarkers [UP to 24 weeks]
Change in lymphocyte counts
Eligibility Criteria
Criteria
Inclusion Criteria:
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
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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
Exclusion Criteria:
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.
- Part 3 only: This exclusion does not apply to plaque psoriasis
-
History or presence of cancer
-
Presence of pre-cancerous conditions
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History or presence of a systemic infection or any potentially opportunistic infections
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charite Research Organisation GmbH | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Francisco Ramirez-Valle, MD, PhD, Celgene
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-92252-CP-001
- U1111-1229-5867
- 2018-001050-10