A Safety Study of CC-92252 in Healthy Adult Subjects and Adult Subjects With Psoriasis

NCT03971825 | Terminated Phase 1 FDA Drug

• 3 other identifiers: CC-92252-CP-001U1111-1229-58672018-001050-10
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Psoriasis

Keywords

Psoriasis; Healthy Volunteer; Safety; CC-92252

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse event

  From enrollment until at least 28 days after completion of study treatment

Secondary Outcomes (11)

• Pharmacokinetics - Cmax

  Up to 16 weeks

• Pharmacokinetics - AUC0-t

  Up to 16 weeks

• Pharmacokinetics - AUC0-∞

  Up to 16 weeks

• Pharmacokinetics - Tmax

  Up to 16 weeks

• Pharmacokinetics - t1/2z

  UP to 16 weeks

Study Arms (2)

Administration of CC-92252 and Placebo in Healthy Subjects

EXPERIMENTAL

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; Other: Placebo

Administration of CC-92252 and Placebo in Psoriasis subjects

EXPERIMENTAL

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; Other: Placebo

Interventions

CC-92252 DRUG

CC-92252

Administration of CC-92252 and Placebo in Healthy Subjects; Administration of CC-92252 and Placebo in Psoriasis subjects

Placebo OTHER

Placebo

Administration of CC-92252 and Placebo in Healthy Subjects; Administration of CC-92252 and Placebo in Psoriasis subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Charite Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Francisco Ramirez-Valle, MD, PhD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 3, 2019
• Study Start: July 24, 2018
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (1)