- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866317
A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
A Pilot Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
Study Overview
Detailed Description
Discoid lupus erythematosus (DLE) is a cutaneous manifestation of lupus that can exist either as part of systemic lupus erythematosus (SLE), or as a chronic cutaneous condition with no systemic involvement. While the skin-limited, chronic form, has no impact on mortality, it can have significant morbidity, as lesions are painful and scarring. While some patients respond well to use of steroids, whether topical or intralesional, antimalarials such as hydroxychloroquine, or traditional immuno-suppressants there is a significant proportion of patients who remain non-responsive to these treatments, or require high dosages of these, oral steroids, or experimental therapies to suppress the condition. For this group of patients there is a high clinical need to find alternate therapies.
Although the pathways of inflammation are poorly understood, one cytokine of potential interest is IL-17A. Immunohistochemical analysis of skin samples from 89 subjects showed that expression of IL-17A was higher in DLE, SCLE and SLE patients than in negative control subjects (all p<0.05). Serum IL-17A concentrations were higher in DLE and SLE patients than in negative controls (p<0.05), a finding confirmed in studies of DLE in different populations.
Recently secukinumab (Cosentyx), an anti-IL-17A monoclonal antibody, has been approved for use in psoriasis after rapid and sustained results in clinical trials. It has also found promise in other inflammatory conditions where IL-17A signaling is believed to be important, such as uveitis.
Given its good safety profile, its impressive response in psoriasis and steroid-unresponsive inflammatory conditions, and the immunohistochemical evidence that IL-17A may be important in the inflammatory path of DLE, the investigators propose a pilot study of secukinumab in discoid lupus erythematosus.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- CURTIS (Massachusetts General Hospital)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subject 18 years of age or older
- Subjects with moderate to severe DLE with at least one active discoid target lesion (0.5-1.0 cm2), with CLASI ≥ 5.
- Willingness of subject to follow all study procedures
- Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
Exclusion Criteria:
- Pregnancy or breast feeding
- Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
- Systemic Lupus Erythematosus (SLE) as defined by ACR criteria
- Known hypersensitivity to any of the constituents or excipients of the investigational product
- Use of any prescription or non-prescription medication that could interfere with efficacy evaluations in the study
- Change in use of systemic DLE therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, in the past 1 month.
- Use of systemic pain medications, e.g. oxycodone in the past 2 weeks
- Participation in another clinical research study with an investigational drug within 4 weeks before this study
- Use of immune-suppressant or other biological treatment
- Starting antimalarial medicine after enrolling in the study. Subjects who are already on a stable dose of antimalarial before enrollment, may continue the same dose.
- An ongoing infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Secukinumab
Secukinumab 300 mg injection at week 0, 1, 2, 3, 4, then every 4 weeks until week 12
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All subjects will receive secukinumab 300 mg injections subcutaneously at week 0, 1, 2, 3, 4, then every 4 weeks until week 12.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the efficacy of Secukinumab in Discoid Lupus Erythematosus by clinical responder rate at week 16.
Time Frame: 16 week
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By using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
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16 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gideon Smith, MD, Mass. General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P000403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Discoid Lupus Erythematosus
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Florida Academic Dermatology CentersUnknownDiscoid Lupus Erythematosus (DLE)United States
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LEO PharmaTerminatedDiscoid Lupus ErythematosusUnited States, France, Germany, Denmark
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Al-Azhar UniversityCompleted
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University of RochesterIncyte CorporationCompletedDiscoid Lupus ErythematosusUnited States
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CelgeneTerminatedDiscoid LupusUnited States
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AmgenTerminatedSystemic Lupus Erythematosus | Cutaneous Lupus | Lupus | Discoid LupusUnited States
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AmgenCompleted
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NYU Langone HealthCelgene CorporationCompletedDiscoid Lupus ErythematosusUnited States
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The Cleveland ClinicWithdrawnDiscoid Lupus Erthematosus of the ScalpUnited States
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Innovaderm Research Inc.Not yet recruitingDiscoid Lupus ErythematosusCanada
Clinical Trials on Secukinumab
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Novartis PharmaceuticalsRecruiting
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Technical University of MunichNovartisCompletedPyoderma GangrenosumGermany
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Novartis PharmaceuticalsCompletedPlaque PsoriasisThailand
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Novartis PharmaceuticalsCompletedPlaque PsoriasisUnited States
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University of Erlangen-Nürnberg Medical SchoolActive, not recruiting
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Novartis PharmaceuticalsCompletedPsoriatic Arthritis | Axial SpondyloarthritisSpain
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Novartis PharmaceuticalsCompletedPsoriasisUnited States
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Saakshi KhattriCompleted
-
Taizhou Mabtech Pharmaceutical Co.,LtdRecruiting
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Novartis PharmaceuticalsActive, not recruitingPsoriatic Arthritis | Ankylosing Spondylitis | Moderate to Severe Plaque Psoriasis | Non-radiographic Axial SpondyloarthritisThailand