A Phase 2 Study With CC-220 in Skin Sarcoidosis

Phase 2WithdrawnNCT02192489

Celgene

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Sarcoidosis

Interventions

CC-220 0.3 mg DailyDRUG

CC-220 0.6mg DailyDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 weeks

Secondary Outcomes

Improvement in modified Sarcoidosis Activity and Severity Index

Proportion of subjects who achieve a ≥ 1-point change in the index lesion as measured by the cutaneous sarcoidosis outcome instrument (modified Sarcoidosis Activity and Severity Index) as compared to baseline

Time frame: Week 4, 8 and 12

Improvement in lesion induration

Change from baseline in lesion induration via dermascope compared to Week 12

Time frame: Week 12

Improvement in sarcoidosis disease markers

Change from baseline in sarcoidosis disease markers: serum angiotensin converting enzyme (ACE), Immunoglobulin G (IgG) levels, 25-hydroxy vitamin D (25-OH-vit D), and 1,25-dihydroxy vitamin D (1,25-vit D) as compared to Weeks 4, 8 and 12.

Time frame: Weeks 4, 8, 12

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

Maximum observed plasma concentration after a single dose on Day 1 or multiple doses on Day 29).

Time frame: 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)

Area under the plasma concentration time-curve from time 0 to the last quantifiable concentration at time t following a single dose (day 1) and multiple doses (Day 29) determined using the trapezoidal method (non-compartmental analysis).

Data from ClinicalTrials.gov

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