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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001065-27 | EudraCT Number |
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Administrative
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-220 0.3mg | Experimental | CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks |
|
| CC-220 0.6mg | Experimental | CC-220 0.6mg capsules by PO daily for 12 weeks |
|
| Placebo | Placebo Comparator | Identically matching placebo PO daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-220 0.3 mg Daily | Drug |
| ||
| CC-220 0.6mg Daily |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 4, 8 and 12 |
| Improvement in lesion induration |
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Inclusion Criteria:
Males or females aged ≥ 18 years at the time of consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yufang Lu, MD, PhD | Celgene Corporation | Study Director |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| C000624220 | iberdomide |
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| Placebo | Drug |
|
Change from baseline in lesion induration via dermascope compared to Week 12 |
| 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. | 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). | 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). | 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 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. | Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose |
| 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 | Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose |
| 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 | Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose |
| 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 | Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose |
| 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). | Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |