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A Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Active Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT02953821
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Subjects with active systemic lupus erythematosus (SLE) will be randomized to receive Acthar or placebo. Active treatment will continue for 24 weeks. Efficacy will be assessed at multiple timepoints using the SLE Responder Index (SRI), SLEDAI-2K, BILAG, PGA, CLASI and 28 Joint Count

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Repository corticotropin injection Drug: Placebo gel Phase 4

Detailed Description:
This is a randomized, placebo controlled, double blind study. Following a screening period of up to 28 days, subjects with active systemic lupus erythematosus (SLE) including moderate to severe rash and/or arthritis despite corticosteroid therapy will be randomized in a 1:1 ratio to receive 1 mL (80 Units [U]) of Acthar or matching placebo. During Weeks 1 to 4, 1 mL (80 U) of Acthar or volume matched placebo will be administered subcutaneously (SC) every other day. For the remainder of the study (Weeks 5 to 24), Acthar 1 mL (80 U) or volume matched placebo will be administered SC 2x/week.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids
Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Repository corticotropin injection
During Weeks 1 to 4, 1 mL (80 U) of repository corticotropin injection will be administered subcutaneously (SC) every other day. During Weeks 5 to 24, repository corticotropin injection 1 mL (80 U) will be administered SC 2x/week.
Drug: Repository corticotropin injection
Other Name: H.P. Acthar Gel
Placebo Comparator: Placebo gel
During Weeks 1 to 4, 1 mL of Placebo gel will be administered subcutaneously (SC) every other day. During Weeks 5 to 24, Placebo gel 1 mL will be administered SC 2x/week.
Drug: Placebo gel


Outcome Measures

Primary Outcome Measures :
  1. Proportion of responders assessed by the SLE Responder Index [ Time Frame: 16 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in SLE disease activity measure [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Subjects must be ≥18 years of age at Screening Visit 2.Subjects must have a diagnosis of SLE according to the American College of Rheumatology revised criteria (fulfilled ≥4 criteria).

3.Subjects must have active SLE as demonstrated by a SLEDAI-2K score of ≥6 at the Screening Visit and a clinical SLEDAI (excluding laboratory results) score ≥4 at the Screening and Randomization Visits. Points for arthritis and/or rash must be present at both the Screening and Randomization Visits.

4.Subjects must have a documented history of positive antinuclear antibody (ANA), OR a screening result of positive ANA, OR a documented history or positive screening result of elevated anti-dsDNA or ENA antibodies 5.Subjects must have been on prednisone (or prednisone equivalent) for ≥8 weeks prior to the Screening Visit and on a stable dose of 7.5 mg to 30 mg of prednisone (or prednisone equivalent) for ≥ 4 weeks prior to the Screening Visit.

Exclusion criteria:

  1. Subject has a history of sensitivity to ACTH preparations or porcine products
  2. Subject has active lupus nephritis
  3. Subject has active CNS manifestations of SLE
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953821


Contacts
Contact: Leonor Nazareno 800-556-3314 clinicaltrials@mallinckrodt.com

  Show 32 Study Locations
Sponsors and Collaborators
Mallinckrodt
More Information

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02953821     History of Changes
Other Study ID Numbers: MNK14304067
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs