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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 : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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 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
Actual Study Start Date : October 13, 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

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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: Lizelyn Foley 800-556-3314 clinicaltrials@mnk.com

  Hide Study Locations
Locations
United States, Arizona
Arizona Arthritis and Rheumatology Research Recruiting
Mesa, Arizona, United States, 85202
United States, California
C.V. Mehta MD Medical Corporation Recruiting
Hemet, California, United States, 92543
C.V. Mehta MD Medical Corporation Recruiting
Riverside, California, United States, 92518
Inland Rheumatology Clinical Trials Recruiting
Upland, California, United States, 91786
United States, Florida
Center for Rheumatology Immunology and Arthritis Recruiting
Fort Lauderdale, Florida, United States, 33309
Precision Research Organization Recruiting
Miami Lakes, Florida, United States, 33016
San Marcus Research Clinic Recruiting
Miami, Florida, United States, 33015
Advanced Pharma CR Recruiting
Miami, Florida, United States, 33147
Omega Research Consultants-DeBary Recruiting
Orlando, Florida, United States, 32713
Millennium Research Recruiting
Ormond Beach, Florida, United States, 32174
Clinical Research of West Florida - Tampa Recruiting
Tampa, Florida, United States, 33603
United States, Georgia
Primary Care Research Recruiting
Atlanta, Georgia, United States, 30342
Omega Research Dalton Recruiting
Dalton, Georgia, United States, 30720
iResearch Atlanta Recruiting
Decatur, Georgia, United States, 30030
United States, Michigan
June DO, PC Recruiting
Lansing, Michigan, United States, 48910
United States, Nevada
Office of George Timothy Kelly MD Recruiting
Las Vegas, Nevada, United States, 89128
United States, New Mexico
Albuquerque Clinical Trials Recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
NewYork-Presbyterian Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, North Carolina
DJL Clinical Research Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Paramount Medical Research & Consulting Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
ACME Research, LLC Recruiting
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
West Tennessee Physicians' Alliance Recruiting
Jackson, Tennessee, United States, 38305
New Phase Research and Development Recruiting
Knoxville, Tennessee, United States, 37909
Ramesh C. Gupta, MD Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Accurate Clinical Research Recruiting
Houston, Texas, United States, 77034
Sun Research Institute Recruiting
San Antonio, Texas, United States, 78215
Argentina
Aprillus Asistencia e Investigación Recruiting
Buenos Aires, Argentina, C1046AAQ
Consultorios Médicos Dr. Catalán Pellet Recruiting
Buenos Aires, Argentina, C1111AAL
Centro Polivalente de Asistencia e Investigación Clínica CER San Juan Recruiting
San Juan, Argentina, J5402DIL
Centro Medico Privado de Reumatología Recruiting
Tucumán, Argentina, T4000AXL
Chile
Quantum Research - Santiago Recruiting
Providencia, Chile, 7500588
Servicios Profesionales SMOLAM Recruiting
Providencia, Chile, 7500739
Biomedica Research Group Recruiting
Santiago, Chile, 7500710
Colombia
Centro de Reumatologia y Ortopedia Not yet recruiting
Barranquilla, Atlantico, Colombia
Centro Integral de Reumatologia Circaribe Not yet recruiting
Barranquilla, Atlantico, Colombia
Centro Integral de Reumatologia Reumalab Not yet recruiting
Cali, Valle Del Cauca, Colombia
Centro Medico Julian Coronel Not yet recruiting
Cali, Valle Del Cauca, Colombia
Mexico
Unidad de Investigación de las Enfermedades Reumáticas Recruiting
Ciudad de mexico, Mexico, 06090
Centro de Estudios Clínicos y Especialidades Médicas Recruiting
Monterrey, Mexico, 64620
Centro Peninsular de Investigacion Clinica S.C.P. Recruiting
Mérida, Mexico, 97000
Consultorio de Reumatología Recruiting
México, Mexico, 07760
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC Recruiting
San Luis Potosí, Mexico, 78213
Peru
Clinica Vesalio Recruiting
San Borja, Peru, 15036
Hospital de Apoyo Maria Auxiliadora Recruiting
San Juan De Miraflores, Peru, 15801
Clínica Médica Cayetano Heredia Recruiting
San Martin De Porres, Peru, 15102
Hospital Nacional Cayetano Heredia Recruiting
San Martin De Porres, Peru, 15102
Sponsors and Collaborators
Mallinckrodt

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: March 20, 2018
Last Verified: March 2018

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