A Phase 2 Study With CC-220 in Skin Sarcoidosis

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Primary Purpose

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

CC-220 0.3 mg Daily

CC-220 0.6mg Daily

Placebo

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Chronic Cutaneous Sarcoidosis, Cutaneous Sarcoidosis, Skin Sarcoidosis, Sarcoidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

CC-220 0.3mg

CC-220 0.6mg

Placebo

Arm Description

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

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

Identically matching placebo PO daily for 12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Improvement in lesion induration

Change from baseline in lesion induration via dermascope compared to 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.

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).

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).

Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Single and Multiple Doses (AUC0-inf)

The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for CC-220 after a single dose on day 1 and multiple doses on Day 29, calculated by the linear trapezoidal rule and extrapolated to infinity.

Pharmacokinetics - Terminal Phase Half-life (t1/2) After Single and Multiple Doses

Terminal phase elimination half-life (t1/2) after a single dose on day 1 and multiple doses on Day 29

Pharmacokinetics - Apparent Volume of Distribution (Vz/f) After Single and Multiple Doses

Apparent volume of distribution after a single dose on day 1 and multiple doses on Day 29, based on the terminal phase after a orally administration

Pharmacokinetics - Apparent Total Clearance of CC-220 (CL/F) After Single and Multiple Doses

The apparent total clearance after a single dose on Day 1 and multiple doses Day 29, calculated as Dose/AUC0-inf

Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) After Single and Multiple Doses

The time to first maximum observed plasma concentration of CC-220 after a single dose (Day 1) or multiple doses (Day 29).

Full Information

NCT ID

NCT02192489

First Posted

July 15, 2014

Last Updated

November 7, 2019

Sponsor

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT02192489

Brief Title

A Phase 2 Study With CC-220 in Skin Sarcoidosis

Official Title

A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Administrative

Study Start Date

November 1, 2014 (Anticipated)

Primary Completion Date

June 30, 2017 (Anticipated)

Study Completion Date

June 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoidosis

Keywords

Chronic Cutaneous Sarcoidosis, Cutaneous Sarcoidosis, Skin Sarcoidosis, Sarcoidosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CC-220 0.3mg

Arm Type

Experimental

Arm Description

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

Arm Title

CC-220 0.6mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Identically matching placebo PO daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

CC-220 0.3 mg Daily

Intervention Type

Drug

Intervention Name(s)

CC-220 0.6mg Daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of participants with adverse events (AEs)

Description

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 Outcome Measure Information:

Title

Improvement in modified Sarcoidosis Activity and Severity Index

Description

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

Title

Improvement in lesion induration

Description

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

Time Frame

Week 12

Title

Improvement in sarcoidosis disease markers

Description

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

Title

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

Description

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

Time Frame