Cutaneous Lupus Erythematosus (CLE)NCT00633945
Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE)
A study testing Lenalidomide in people with Cutaneous Lupus Erythematosus (CLE), run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must understand and voluntarily sign Informed Consent and HIPAA forms.
- Males and females over the age of 18 at the time of signing informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements
- Subjects must have biopsy proven Cutaneous Lupus Erythematosus (CLE) either in the form of Discoid Lupus Erythematosus (DLE) or Subacute Lupus Erythematosus (SCLE), with or without systemic involvement.
- Subjects must have grade II erythema in at least three skin locations as defined by the Cutaneous Lupus Activity and Severity Index (CLASI).
- Subjects must have failed standard treatment with hydroxychloroquine (Plaquenil) for up to three months.
Show all 9Show fewer
- Female subjects who are not pregnant.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional method AT THE SAME TIME, at least 28 days before starting to take lenalidomide (Revlimid®). FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- If pregnancy or a positive pregnancy test is noted in a study subject or in the partner of a male study subject during study participation, the study drug must be discontinued immediately.
Who cannot join
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
- Female subjects who are pregnant, plan to be pregnant during the study, or who are breastfeeding.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk for study participation, or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Show all 17Show fewer
- Prior history of deep vein thrombosis (DVT).
- Prior history of pulmonary embolus (PE).
- Known positive for HIV viral DNA by qPCR.
- Positive hepatitis B surface antigen, or hepatitis C.
- Platelet count < 50,000/mcL.
- Absolute neutrophil count < 750/mcL
- Lymphopenia < 500/mcL.
- Have current signs or symptoms of severe progressive or uncontrolled renal disease (creatinine ≥1.5 x ULN).
- If female, unwillingness to use one highly effective method and one additional method of birth control.
- If male, unwillingness to use a latex condom during intercourse with females of childbearing potential.
- Continued therapy with thalidomide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of Lenalidomide (REVLIMID®) in Cutaneous LE: A Prospective, Non Controlled, Open Label Pilot Study to Evaluate the Off-Label Use of the FDA-approved Drug Lenalidomide (REVLIMID®) in Patients With Cutaneous Lupus Erythematosus
This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will be included in the study.
Read the detailed description
Cutaneous lupus erythematosus (CLE) is a chronic and often disabling disease which affects the skin. Many patients experience scarring and inflammation of the skin, which often occur on the face. Moderate to severe CLE is most frequently treated with antimalarial drugs such as hydroxychloroquine, quinacrine or chloroquine. Up to 70% of CLE patients treated with antimalarials experience a beneficial clinical response, while the remainder of patients show no response or continue to experience progression of the disease. Thalidomide has been used successfully in such patients, with up to 75% clinical response rate in refractory CLE patients. However, thalidomide is a known teratogen and can cause severe birth defects, including short, malformed limbs and damage to peripheral nerves in the extremities, requiring patients to be monitored for pregnancy. In addition, up to 25% of patients on thalidomide develop peripheral neuropathy. A new drug, lenalidomide (REVLIMID®), an analogue of thalidomide, has been developed to treat neoplastic and inflammatory conditions, including various oncologic conditions such as multiple myeloma, myelodysplastic syndrome and solid tumors. Unlike thalidomide, lenalidomide (REVLIMID®) is not known to cause the extent of serious side effects caused by thalidomide; however, it must also be monitored for side effects and be distributed under the RevAssist program authorized by the drug manufacturer, Celgene Corporation.
The primary goal of this investigator-initiated, small pilot study is to evaluate the safety and effectiveness of lenalidomide (REVLIMID®) in CLE subjects using measurements such as the CLASI (Cutaneous Lupus Activity and Severity Index). The study drug will be used in an off-label indication to treat 6 subjects, for whom lenalidomide (REVLIMID®) will be provided at no cost by the drug manufacturer. Men and women over the age of 18, who have a biopsy proven diagnosis of refractory CLE and who have failed standard treatment with hydroxychloroquine for up to three months, will be included in the study. Secondarily, the study will evaluate the biologic effects of lenalidomide on pathogenic and immunologic mechanisms of the CLE disease process during the treatment period by collecting skin specimens (biopsies) and blood samples.
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Being tested
- Lenalidomide
- Keywords
- Cutaneous Lupus Erythematosus, CLE, lenalidomide, revlimid, thalidomide derivative, drug, lupus
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Open label lenalidomide received. Receives: Drug: Lenalidomide |
| Lenalidomide 2 | Experimental | Open label lenalidomide received. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Lupus Area and Severity Index (CLASI)
The Cutaneous Lupus Area and Severity Index (CLASI); range of disease activity is 0-70. Lower scores reflect less activity.
Measured: Weeks 0 through 52
Secondary outcomes (8)
Number of Participants With Change in IFN and CD4 Levels at 6 Weeks
CXCL10, an interferon-inducible chemokine, and immunophenotyping by immunostaining. Measurement of interferon-inducible genes from peripheral blood mononuclear cells before and after treatment.
Measured: 6 weeks
Physician Global Assessment (PGA) for Skin
General skin scores were recorded on a 10 cm visual analogue scale at each visit. At each visit on scale 0-10, 0 corresponding to worst skin condition imaginable and 10 to perfect health.
Measured: Weeks 0 through 52
Patient General Assessment (PtGA) for Skin
General skin scores were recorded by the patient on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to worst skin condition imaginable and 10 to perfect health.
Measured: Weeks 0 through 52
Pain in Skin
Pain in skin was recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no pain and 10 to pain as bad as you can imagine.
Measured: Weeks 0 through 52
Itch in Skin
Itch scores were recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no itch and 10 to itch as bad as you can imagine.
Measured: Weeks 0 through 52
Fatigue
Fatigue scores were recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no fatigure and 10 to fatigue as bad as you can imagine.
Measured: Weeks 0 through 52
Skindex Symptoms
Skindex symptoms scores are scored 1-5 and then normalized to 100, with a higher score corresponding to a worse impression. The absence of symptom impact on QoL is scored as "20" (this is represented as a 1 on the 1-5 scale. The worst impact of symptoms on QoL is 100. This is represented as a 5 on the 1-5 scale.
Measured: Weeks 0 through 52
Skindex Function
Skindex function scores are scored 1-5 and then normalized to 100, with a higher score corresponding to a worse impression. The absence of function impact on QoL is scored as "20" (this is represented as a 1 on the 1-5 scale. The worst impact of function on QoL is 100. This is represented as a 5 on the 1-5 scale.
Measured: Weeks 0 through 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Lupus Erythematosus (CLE)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Victoria P Werth, MD, Principal investigator, University of Pennsylvania, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633945
- Sponsor's protocol ID
- 806259
- Status last verified
- Feb 2023
- First submitted
- 4 Mar 2008
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Okon L, Rosenbach M, Krathen M, Rose M, Propert K, Okawa J, Werth V. Lenalidomide in treatment-refractory cutaneous lupus erythematosus: Efficacy and safety in a 52-week trial. J Am Acad Dermatol. 2014 Mar;70(3):583-4. doi: 10.1016/j.jaad.2013.11.007. No abstract available.
PubMed 24528907
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lenalidomide (REVLIMID®) in Cutaneous LE: A Prospective, Non Controlled, Open Label Pilot Study to Evaluate the Off-Label Use of the FDA-approved Drug Lenalidomide (REVLIMID®) in Patients With Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00633945
- Acronym / sponsor ID
- 806259
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Keywords
- Cutaneous Lupus Erythematosus, CLE, lenalidomide, revlimid, thalidomide derivative, drug, lupus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will be included in the study.
Detailed description
Cutaneous lupus erythematosus (CLE) is a chronic and often disabling disease which affects the skin. Many patients experience scarring and inflammation of the skin, which often occur on the face. Moderate to severe CLE is most frequently treated with antimalarial drugs such as hydroxychloroquine, quinacrine or chloroquine. Up to 70% of CLE patients treated with antimalarials experience a beneficial clinical response, while the remainder of patients show no response or continue to experience progression of the disease. Thalidomide has been used successfully in such patients, with up to 75% clinical response rate in refractory CLE patients. However, thalidomide is a known teratogen and can cause severe birth defects, including short, malformed limbs and damage to peripheral nerves in the extremities, requiring patients to be monitored for pregnancy. In addition, up to 25% of patients on thalidomide develop peripheral neuropathy. A new drug, lenalidomide (REVLIMID®), an analogue of thalidomide, has been developed to treat neoplastic and inflammatory conditions, including various oncologic conditions such as multiple myeloma, myelodysplastic syndrome and solid tumors. Unlike thalidomide, lenalidomide (REVLIMID®) is not known to cause the extent of serious side effects caused by thalidomide; however, it must also be monitored for side effects and be distributed under the RevAssist program authorized by the drug manufacturer, Celgene Corporation.
The primary goal of this investigator-initiated, small pilot study is to evaluate the safety and effectiveness of lenalidomide (REVLIMID®) in CLE subjects using measurements such as the CLASI (Cutaneous Lupus Activity and Severity Index). The study drug will be used in an off-label indication to treat 6 subjects, for whom lenalidomide (REVLIMID®) will be provided at no cost by the drug manufacturer. Men and women over the age of 18, who have a biopsy proven diagnosis of refractory CLE and who have failed standard treatment with hydroxychloroquine for up to three months, will be included in the study. Secondarily, the study will evaluate the biologic effects of lenalidomide on pathogenic and immunologic mechanisms of the CLE disease process during the treatment period by collecting skin specimens (biopsies) and blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: LenalidomideOpen label lenalidomide received. |
| Lenalidomide 2 | Experimental | Drug: LenalidomideOpen label lenalidomide received. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must understand and voluntarily sign Informed Consent and HIPAA forms.
- Males and females over the age of 18 at the time of signing informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements
- Subjects must have biopsy proven Cutaneous Lupus Erythematosus (CLE) either in the form of Discoid Lupus Erythematosus (DLE) or Subacute Lupus Erythematosus (SCLE), with or without systemic involvement.
- Subjects must have grade II erythema in at least three skin locations as defined by the Cutaneous Lupus Activity and Severity Index (CLASI).
Key exclusion criteria (17 listed)
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
- Female subjects who are pregnant, plan to be pregnant during the study, or who are breastfeeding.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk for study participation, or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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 |
|---|---|---|
| Lenalidomide | Drug | Lenalidomide, Lenalidomide 2 |
Primary outcome
Cutaneous Lupus Area and Severity Index (CLASI)
Time frame: Weeks 0 through 52
The Cutaneous Lupus Area and Severity Index (CLASI); range of disease activity is 0-70. Lower scores reflect less activity.
8 secondary outcomes
Number of Participants With Change in IFN and CD4 Levels at 6 Weeks
Time frame: 6 weeks
Physician Global Assessment (PGA) for Skin
Time frame: Weeks 0 through 52
Patient General Assessment (PtGA) for Skin
Time frame: Weeks 0 through 52
Pain in Skin
Time frame: Weeks 0 through 52
Itch in Skin
Time frame: Weeks 0 through 52
Fatigue
Time frame: Weeks 0 through 52
Skindex Symptoms
Time frame: Weeks 0 through 52
Skindex Function
Time frame: Weeks 0 through 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24528907Okon L, Rosenbach M, Krathen M, Rose M, Propert K, Okawa J, Werth V. Lenalidomide in treatment-refractory cutaneous lupus erythematosus: Efficacy and safety in a 52-week trial. J Am Acad Dermatol. 2014 Mar;70(3):583-4. doi: 10.1016/j.jaad.2013.11.007. No abstract available.
Related trials for Cutaneous Lupus Erythematosus (CLE)
Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
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)
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
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
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.
Victoria P Werth, MD principal investigator
University of Pennsylvania, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenalidomide in people with Cutaneous Lupus Erythematosus (CLE), run by University of Pennsylvania at 1 site 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 9 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: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cutaneous Lupus Area and Severity Index (CLASI) (time frame: Weeks 0 through 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633945, which also lists 1 linked publication.
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 9 Feb 2023.