A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus

August 31, 2021 updated by: Gideon Piers Smith, Massachusetts General Hospital

A Pilot Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus

Discoid lupus erythematosus is a chronic inflammatory skin condition and may lead to itch, skin pain, open sores, scarring, disfigurement and hair loss. Studies have shown that IL-17A may play a major role in inflammation and in the pathogenesis of discoid lupus. Treatment of discoid lupus sometimes is a challenge and unresponsive to current therapies. Secukinumab, an anti-IL-17A monoclonal antibody has been safe and effective in the treatment of psoriasis. The investigators propose to study the efficacy and safety of secukinumab in discoid lupus.

Study Overview

Status

Withdrawn

Intervention / Treatment

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

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • CURTIS (Massachusetts General Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subject 18 years of age or older
  2. Subjects with moderate to severe DLE with at least one active discoid target lesion (0.5-1.0 cm2), with CLASI ≥ 5.
  3. Willingness of subject to follow all study procedures
  4. Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion Criteria:

  1. Pregnancy or breast feeding
  2. 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
  3. Systemic Lupus Erythematosus (SLE) as defined by ACR criteria
  4. Known hypersensitivity to any of the constituents or excipients of the investigational product
  5. Use of any prescription or non-prescription medication that could interfere with efficacy evaluations in the study
  6. Change in use of systemic DLE therapy, e.g. systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, in the past 1 month.
  7. Use of systemic pain medications, e.g. oxycodone in the past 2 weeks
  8. Participation in another clinical research study with an investigational drug within 4 weeks before this study
  9. Use of immune-suppressant or other biological treatment
  10. 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.
  11. An ongoing infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Secukinumab
Secukinumab 300 mg injection at week 0, 1, 2, 3, 4, then every 4 weeks until week 12
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:
  • Cosentyx

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
By using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
16 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Gideon Smith, MD, Mass. General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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.

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