Cutaneous Lupus ErythematosusPhase 2NCT01300208
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
A Phase 2 study testing CC-11050 in people with Cutaneous Lupus Erythematosus, run by Amgen at 19 sites in United States.
Trial summary
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- CC-11050
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 19 sitesUnited States
- Study dates
- 1 Oct 2010to 1 Mar 2013
- 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
- Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for > 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determined by the Investigator)
- Must, in the opinion of the Investigator, have active skin lesions of sufficient severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index Activity Score of ≥ 10)
- All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of an ophthalmologic exam performed within 24 weeks of the Baseline Visit.
- Must meet the following laboratory criteria:
- White blood cell count ≥3000/mm3 (≥ 3.0 x 109/L) and < 14,000/mm3 (< 14 x 109/L)
- Absolute neutrophil count (ANC) > 1500 cells/μL (1.5 x 109/L)
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- Platelet count ≥ 100,000/μL (≥ 100 x 109/L)
- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT)
- ≤ 1.5 X upper limit of normal (ULN)
- Total bilirubin < 2mg/dL
- Hemoglobin > 11 g/dL Key Exclusion Criteria
- Participation in multiple CC-11050 cohorts or previous exposure to CC-11050
- Presence or history of SLE based on investigators' clinical evaluation where subject exhibits medically significant (as determined by the Investigator) LE-related pleuritis, pericarditis, neurologic, renal and/or other major SLE-related organ system involvement(SLE-related to SLE joint involvement is acceptable).
- Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
- Use of concomitant disease modifying anti-rheumatic drugs (DMARDs) with the exception of anti-malarials within 4 weeks of screening- Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
- Use of immunosuppressives (eg, azathioprine, mycophenolate mofetil, methotrexate, etc.) within 4 weeks of screening
Who cannot join
None listed.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory Univ. School of Medicine
Atlanta, Georgia, 30322
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, 30327
Northwestern University
Chicago, Illinois, 60611
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
UT Southwestern Medical Center Dallas
Dallas, Texas, 75390-9090
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Penn State Hershey Dermatology
Hershey, Pennsylvania, 17033
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, 70605
Dermatology Research Associates
Los Angeles, California, 90045
DermResearch, PLLC
Louisville, Kentucky, 40217
NYU Langone Medical Center
New York, New York, 10016
Central Medaphase Inc
Newnan, Georgia, 30263
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758
Medderm Associates
San Diego, California, 92103
Central Dermatology, P.C.
St Louis, Missouri, 63117
About this study
Official title: A Phase 2, Pilot, Multicenter, Sequential, Ascending Dose Study to Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
- Conditions
- Cutaneous Lupus Erythematosus
- Being tested
- CC-11050, Placebo
- Keywords
- cutaneous lupus erythematosus, subacute lupus erythematosus, discoid lupus erythematosus, lupus
- Medical subject headings
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-11050Drug
Cohort 1: 50 milligrams twice per day for 4 weeks Cohort 2: 100 milligrams twice per day for 8 weeks Cohort 3: 200 milligrams twice per day for 12 week
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | CC-11050 (50 milligrams twice per day and Placebo) Receives: Drug: CC-11050; Other: Placebo |
| Cohort 2 | Experimental | CC-11050 (100 milligrams twice per day and Placebo) Receives: Drug: CC-11050; Other: Placebo |
| Cohort 3 | Experimental | CC-11050 (200 milligrams twice per day and Placebo) Receives: Drug: CC-11050; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern
Measured: Up to 21 weeks
Secondary outcomes (8)
Pharmacokinetics (PK)
To describe the area under the curve (AUC) of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment
Measured: 12 weeks
Pharmacokinetics (PK)
To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
Pharmacokinetics
To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
Pharmacokinetics (PK)
To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
Pharmacokinetics (PK)
To describe the half life (t1/2) of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
Pharmacokinetics (PK)
To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
Pharmacokinetics (PK)
To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma
Measured: Up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study start1 Oct 2010
- Primary completion1 Jan 2013
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300208
- Sponsor's protocol ID
- CC-11050-CLE-002
- Status last verified
- Jun 2020
- First submitted
- 18 Oct 2010
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Pilot, Multicenter, Sequential, Ascending Dose Study to Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01300208
- Acronym / sponsor ID
- CC-11050-CLE-002
- Conditions
- Cutaneous Lupus Erythematosus
- Keywords
- cutaneous lupus erythematosus, subacute lupus erythematosus, discoid lupus erythematosus, lupus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 21 Feb 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.
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CC-11050, Other: PlaceboCC-11050 (50 milligrams twice per day and Placebo) |
| Cohort 2 | Experimental | Drug: CC-11050, Other: PlaceboCC-11050 (100 milligrams twice per day and Placebo) |
| Cohort 3 | Experimental | Drug: CC-11050, Other: PlaceboCC-11050 (200 milligrams twice per day and Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for > 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determined by the Investigator)
- Must, in the opinion of the Investigator, have active skin lesions of sufficient severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index Activity Score of ≥ 10)
- All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of an ophthalmologic exam performed within 24 weeks of the Baseline Visit.
- Must meet the following laboratory criteria:
- Participation in multiple CC-11050 cohorts or previous exposure to CC-11050
Key exclusion criteria (0 listed)
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-11050Cohort 1: 50 milligrams twice per day for 4 weeks Cohort 2: 100 milligrams twice per day for 8 weeks Cohort 3: 200 milligrams twice per day for 12 week | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Placebo | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern
Time frame: Up to 21 weeks
8 secondary outcomes
Pharmacokinetics (PK)
Time frame: Up to 21 weeks
To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment
Time frame: 12 weeks
Pharmacokinetics (PK)
Time frame: Up to 21 weeks
Pharmacokinetics
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
Time frame: Up to 21 weeks
Pharmacokinetics (PK)
Time frame: Up to 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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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.
MD study director
Amgen
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-11050 in people with Cutaneous Lupus Erythematosus, run by Amgen 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 17 inclusion and 0 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: finished, as of the sponsor's last update on 23 Jun 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern (time frame: Up to 21 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 23 Jun 2020.