Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE)

NCT00633945 | Completed Results DMC

• 1 other identifier: 806259
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cutaneous Lupus Erythematosus (CLE)

Keywords

Cutaneous Lupus Erythematosus; CLE; lenalidomide; revlimid; thalidomide derivative; drug; lupus

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 0 through 52

Secondary Outcomes (8)

• Number of Participants With Change in IFN and CD4 Levels at 6 Weeks

  6 weeks

• Physician Global Assessment (PGA) for Skin

  Weeks 0 through 52

• Patient General Assessment (PtGA) for Skin

  Weeks 0 through 52

• Pain in Skin

  Weeks 0 through 52

• Itch in Skin

  Weeks 0 through 52

Study Arms (2)

Lenalidomide

EXPERIMENTAL

Open label lenalidomide received.

Drug: Lenalidomide

Lenalidomide 2

EXPERIMENTAL

Open label lenalidomide received.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide; Lenalidomide 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Celgene Corporation: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania, Department of Dermatology

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 24528907 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

This study is limited by small sample size and open label design.

Results Point of Contact

• Title: Dr. Victoria Werth
• Organization: University of Pennsylvania

werth@mail.med.upenn.edu

215-898-0168

Study Officials

• Victoria P Werth, MD

  University of Pennsylvania, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: November 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 9, 2023
• Results First Posted: November 13, 2019

Record last verified: 2023-02

Locations

US (1)