- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03971825
A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis
A Phase 1, Randomized, 3-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Charite Research Organisation GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
Placebo
CC-92252
|
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.
|
Placebo
CC-92252
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events (AEs)
Time Frame: From enrollment until at least 28 days after completion of study treatment
|
Number of participants with adverse event
|
From enrollment until at least 28 days after completion of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics - Cmax
Time Frame: Up to 16 weeks
|
Observed maximum serum concentration
|
Up to 16 weeks
|
Pharmacokinetics - AUC0-t
Time Frame: Up to 16 weeks
|
Area under the serum concentration-time curve calculated from time zero to the last measured time point
|
Up to 16 weeks
|
Pharmacokinetics - AUC0-∞
Time Frame: Up to 16 weeks
|
The area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration
|
Up to 16 weeks
|
Pharmacokinetics - Tmax
Time Frame: Up to 16 weeks
|
Time to Cmax
|
Up to 16 weeks
|
Pharmacokinetics - t1/2z
Time Frame: UP to 16 weeks
|
Terminal elimination half-life
|
UP to 16 weeks
|
Pharmacokinetics - CL/F
Time Frame: Up to 16 weeks
|
Apparent clearance of drug from serum after subcutaneous dosing administration
|
Up to 16 weeks
|
Pharmacokinetics - CL
Time Frame: Up to 16 weeks
|
clearance of drug from serum after IV dosing
|
Up to 16 weeks
|
Pharmacokinetics - Vz/F
Time Frame: Up to 16 weeks
|
Apparent volume of distribution during the terminal phase
|
Up to 16 weeks
|
Pharmacokinetics - Vz
Time Frame: Up to 16 weeks
|
Apparent volume of distribution during the terminal phase
|
Up to 16 weeks
|
Anti-drug Antibody Immunogenicity Anti-drug antibody
Time Frame: Up to 16 weeks
|
Evaluation of anti-CC-92252 antibody formation
|
Up to 16 weeks
|
Assessment of Pharmacodynamic biomarkers
Time Frame: UP to 24 weeks
|
Change in lymphocyte counts
|
UP to 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Francisco Ramirez-Valle, MD, PhD, Celgene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC-92252-CP-001
- U1111-1229-5867 (Registry Identifier: WHO)
- 2018-001050-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States