SarcoidosisPhase 2NCT02192489
A Phase 2 Study With CC-220 in Skin Sarcoidosis
A Phase 2 study testing CC-220 0.3 mg Daily and CC-220 0.6mg Daily in people with Sarcoidosis, run by Celgene.
Trial summary
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- CC-220 0.3 mg Daily and CC-220 0.6mg Daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 30 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.
Read the 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
- Conditions
- Sarcoidosis
- Being tested
- CC-220 0.3 mg Daily, CC-220 0.6mg Daily, Placebo
- Keywords
- Chronic Cutaneous Sarcoidosis, Cutaneous Sarcoidosis, Skin Sarcoidosis, Sarcoidosis
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-220 0.3 mg DailyDrug
CC-220 0.6mg DailyDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CC-220 0.3mg | Experimental | CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks Receives: Drug: CC-220 0.3 mg Daily |
| CC-220 0.6mg | Experimental | CC-220 0.6mg capsules by PO daily for 12 weeks Receives: Drug: CC-220 0.6mg Daily |
| Placebo | Placebo comparator | Identically matching placebo PO daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (10)
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
Measured: Week 4, 8 and 12
Improvement in lesion induration
Change from baseline in lesion induration via dermascope compared to Week 12
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start1 Nov 2014 (estimated)
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yufang Lu, MD, PhD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192489
- Sponsor's protocol ID
- CC-220-SAR-001
- Other IDs
- 2014-001065-27, 2014
- Status last verified
- Nov 2019
- First submitted
- 15 Jul 2014
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
- ClinicalTrials.gov ID
- NCT02192489
- Acronym / sponsor ID
- CC-220-SAR-001
- Conditions
- Sarcoidosis
- Keywords
- Chronic Cutaneous Sarcoidosis, Cutaneous Sarcoidosis, Skin Sarcoidosis, Sarcoidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2014 (estimated)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CC-220 0.3mg | Experimental | Drug: CC-220 0.3 mg DailyCC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks |
| CC-220 0.6mg | Experimental | Drug: CC-220 0.6mg DailyCC-220 0.6mg capsules by PO daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIdentically matching placebo PO daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-220 0.3 mg Daily | Drug | CC-220 0.3mg |
| CC-220 0.6mg Daily | Drug | CC-220 0.6mg |
| Placebo | Drug | Placebo |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 12 weeks
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.
10 secondary outcomes
Improvement in modified Sarcoidosis Activity and Severity Index
Time frame: Week 4, 8 and 12
Improvement in lesion induration
Time frame: Week 12
Improvement in sarcoidosis disease markers
Time frame: Weeks 4, 8, 12
Pharmacokinetics- Maximum Plasma Concentration (Cmax) of CC-220 After Single and Multiple Doses
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)
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 Infinity After Single and Multiple Doses (AUC0-inf)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yufang Lu, MD, PhD study director
Celgene Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-220 0.3 mg Daily and CC-220 0.6mg Daily in people with Sarcoidosis, run by Celgene.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.