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

NCT03866317 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2019P000403
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Discoid Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy of Secukinumab in Discoid Lupus Erythematosus by clinical responder rate at week 16.

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

  16 week

Study Arms (1)

Secukinumab

EXPERIMENTAL

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

Drug: Secukinumab

Interventions

Secukinumab DRUG

All subjects will receive secukinumab 300 mg injections subcutaneously at week 0, 1, 2, 3, 4, then every 4 weeks until week 12.

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Novartis: collaborator

Study Sites (1)

CURTIS (Massachusetts General Hospital)

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Gideon Smith, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Department of Dermatology

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 7, 2019
• Study Start: September 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

US (1)