A Phase 2 Study With CC-220 in Skin Sarcoidosis

NCT02192489 | Withdrawn Phase 2

• 2 other identifiers: CC-220-SAR-0012014-001065-27
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.

Conditions

Sarcoidosis

Keywords

Chronic Cutaneous Sarcoidosis; Cutaneous Sarcoidosis; Skin Sarcoidosis; Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs)

  An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health.

  Up to 12 weeks

Secondary Outcomes (10)

• Improvement in modified Sarcoidosis Activity and Severity Index

  Week 4, 8 and 12

• Improvement in lesion induration

  Week 12

• Improvement in sarcoidosis disease markers

  Weeks 4, 8, 12

• Pharmacokinetics- Maximum Plasma Concentration (Cmax) of CC-220 After Single and Multiple Doses

  Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose

• Pharmacokinetics - Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Time Point After Single and Multiple Doses (AUC 0-t)

  Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose

Study Arms (3)

CC-220 0.3mg

EXPERIMENTAL

CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks

Drug: CC-220 0.3 mg Daily

CC-220 0.6mg

EXPERIMENTAL

CC-220 0.6mg capsules by PO daily for 12 weeks

Drug: CC-220 0.6mg Daily

Placebo

PLACEBO COMPARATOR

Identically matching placebo PO daily for 12 weeks

Drug: Placebo

Interventions

CC-220 0.3 mg Daily DRUG

CC-220 0.3mg

CC-220 0.6mg Daily DRUG

CC-220 0.6mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥ 18 years at the time of consent.
• Have chronic cutaneous sacrcoidosis (CCS) prior to consent
• Have active cutaneous sarcoidosis lesion(s) at screening
• Forced vital capacity of ≥ 45% of predicted normal value at screening.
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min.
• Females of childbearing potential must have negative pregnancy tests prior to starting study therapy and agree to either commit to true abstinence or use effective contraception.
• Male subjects must practice true abstinence or agree to use a condom even if he has undergone a successful vasectomy

You may not qualify if:

• Positive tuberculosis test at screening.
• History of inadequately treated tuberculosis
• History of Human Immunodeficiency Virus (HIV) and/or Common Variable Immunodeficiency Disease.
• History of alcohol or drug abuse
• History or current peripheral neuropathy
• Current uveitis or any other clinically significant ophthalmological finding
• Currently require therapy for precapillary pulmonary hypertension.

Sponsors & Collaborators

• Celgene: lead

MeSH Terms

Conditions

Sarcoidosis

Interventions

iberdomide

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Yufang Lu, MD, PhD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: November 1, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 12, 2019

Record last verified: 2019-11