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Trial record 32 of 918 for:    Lupus

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

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ClinicalTrials.gov Identifier: NCT03866317
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Gideon Piers Smith, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE February 27, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date March 7, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
Official Title  ICMJE A Pilot Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Discoid Lupus Erythematosus
Intervention  ICMJE Drug: Secukinumab
All subjects will receive secukinumab 300 mg injections subcutaneously at week 0, 1, 2, 3, 4, then every 4 weeks until week 12.
Other Name: Cosentyx
Study Arms  ICMJE Experimental: Secukinumab
Secukinumab 300 mg injection at week 0, 1, 2, 3, 4, then every 4 weeks until week 12
Intervention: Drug: Secukinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03866317
Other Study ID Numbers  ICMJE 2019P000403
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gideon Piers Smith, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Novartis
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP