A Phase 2 Study With CC-220 in Skin Sarcoidosis

NCT ID: NCT02192489

Last Updated: 2019-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, sequential, dose-ascending, safety and tolerability study in subjects with chronic cutaneous sarcoidosis.

Two dose cohorts of CC-220 (Cohort 1: 0.3 mg by mouth (PO) every day (QD) or matching placebo and Cohort 2: 0.6 mg PO QD or matching placebo) will be evaluated using a sequential, dose-ascending design

Conditions

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Sarcoidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CC-220 0.3mg

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

Group Type EXPERIMENTAL

CC-220 0.3 mg Daily

Intervention Type DRUG

CC-220 0.6mg

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

Group Type EXPERIMENTAL

CC-220 0.6mg Daily

Intervention Type DRUG

Placebo

Identically matching placebo PO daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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CC-220 0.3 mg Daily

Intervention Type DRUG

CC-220 0.6mg Daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yufang Lu, MD, PhD

Role: STUDY_DIRECTOR

Celgene Corporation

Other Identifiers

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2014-001065-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-220-SAR-001

Identifier Type: -

Identifier Source: org_study_id

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