Discoid LupusPhase 2NCT01466725
A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
A Phase 2 study testing CC-930 in people with Discoid Lupus, run by Celgene at 19 sites in United States.
Trial summary
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Discoid Lupus
- What is being tested?
- CC-930
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 19 sitesUnited States
- Study dates
- 1 Nov 2011to 30 Jul 2012
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
- Good health as assessed by Investigator
- DLE for at least 16 weeks prior to screening and consistent histological findings.
- Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
- Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
- Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
- Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
- Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.
Who cannot join
- Significant illnesses as determined by physician.
- History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
- Systolic blood pressure < 95 or > 150 mm Hg
- Diastolic blood pressure > 90 mm Hg.
- Pregnancy or breast feeding.
- Other dermatological conditions that would interfere with CLASI Activity Score assessments.
Show all 17Show fewer
- History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
- Clinically significant abnormality on chest X-ray.
- Participation in multiple CC-930 cohorts.
- History of thrombolytic event.
- Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
- Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
- Diagnosis of SLE.
- Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
- History of seizures, chorea or psychosis.
- Presence or history of persistent proteinuria or urinary cellular casts.
- Prohibited prior or concomitant medications.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
John Hopkins University
Baltimore, Maryland, 21205
UAB Dermatology
Birmingham, Alabama, 35233
Boston Cancer Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush Medical Center
Chicago, Illinois, 60612
Ohio State Univ Medical Center, Division of Dermatology
Columbus, Ohio, 43221
Dermatology and Research
Dallas, Texas, 75230
University of Texas Dermatology
Houston, Texas, 77030
The Regents of the University of California
Irvine, California, 92697
Advanced Pharma, CR, LLC
Miami, Florida, 33136
University of Miami - Department of Dermatology
Miami, Florida, 33136
University of Minnesota-Department of Dermatology
Minneapolis, Minnesota, 55455
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Rhode Island Hospital University Dermatology, Inc.
Providence, Rhode Island, 02903
University of Rochester Medical Center
Rochester, New York, 14623
Sun Research Institute
San Antonio, Texas, 78215
North Shore University Health System
Skokie, Illinois, 60077
SIU School of Medicine
Springfield, Illinois, 62702
Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Read the detailed description
Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;
Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks
- Conditions
- Discoid Lupus
- Being tested
- CC-930, Placebo
- Keywords
- Lupus, Discoid Lupus, DLE, Cutaneous Lupus
- Medical subject headings
- Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-930Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 25 mg daily for 4 weeks (8 active/2 control) Receives: Drug: CC-930; Drug: Placebo |
| Cohort 2 | Experimental | 50 mg once daily for 4 weeks (8 active/2 control) Receives: Drug: CC-930; Drug: Placebo |
| Cohort 3 | Experimental | 100 mg daily for 6 weeks (8 active/2 control) Receives: Drug: CC-930; Drug: Placebo |
| Cohort 4 | Experimental | 100 mg twice daily for 6 weeks (8 active/2 control) Receives: Drug: CC-930; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 4 to 6 weeks
Secondary outcomes (1)
To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study start1 Nov 2011
- Primary completion30 Jul 2012
- Study completion30 Jul 2012
Why it stopped: The benefit/risk profile does not support continuation of this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoid LupusStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Smith, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466725
- Sponsor's protocol ID
- CC-930-DLE-002
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2011
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)
- ClinicalTrials.gov ID
- NCT01466725
- Acronym / sponsor ID
- CC-930-DLE-002
- Conditions
- Discoid Lupus
- Keywords
- Lupus, Discoid Lupus, DLE, Cutaneous Lupus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The benefit/risk profile does not support continuation of this study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 30 Jul 2012 (actual)
- Study completion
- 30 Jul 2012 (actual)
- First posted
- 8 Nov 2011 (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.
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Detailed description
Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;
Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CC-930, Drug: Placebo25 mg daily for 4 weeks (8 active/2 control) |
| Cohort 2 | Experimental | Drug: CC-930, Drug: Placebo50 mg once daily for 4 weeks (8 active/2 control) |
| Cohort 3 | Experimental | Drug: CC-930, Drug: Placebo100 mg daily for 6 weeks (8 active/2 control) |
| Cohort 4 | Experimental | Drug: CC-930, Drug: Placebo100 mg twice daily for 6 weeks (8 active/2 control) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
- Good health as assessed by Investigator
- DLE for at least 16 weeks prior to screening and consistent histological findings.
- Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
- Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
Key exclusion criteria (17 listed)
- Significant illnesses as determined by physician.
- History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
- Systolic blood pressure < 95 or > 150 mm Hg
- Diastolic blood pressure > 90 mm Hg.
- Pregnancy or breast feeding.
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-930 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboPlacebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Number of subjects with adverse events
Time frame: 4 to 6 weeks
1 secondary outcome
To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE.
Time frame: 18 months
Results and safety
The study was stopped early (reason given: The benefit/risk profile does not support continuation of this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
Related trials for Discoid Lupus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Active, not recruitingPhase 2/3
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Systemic Lupus Erythematosus
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
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.
William Smith, MD study director
Celgene
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-930 in people with Discoid Lupus, run by Celgene at 19 sites in United States.
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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 stopped early (reason given: The benefit/risk profile does not support continuation of this study.). Results are not available in the source record.
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 subjects with adverse events (time frame: 4 to 6 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 19 Nov 2019.