Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

NCT02953821 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MNK14304067
• Study Type: interventional
• Target: 172
• Locations: 5 countries
• Sites: 39

Brief Summary

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks:

• Acthar Gel
• Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to:
• see how well the gel is working
• see how safe it is for patients with SLE

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (3)

• Physician's Global Assessment (PGA)

  PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.

  Baseline, Week 16, Week 24

• British Isles Lupus Assessment Group 2004 (BILAG 2004)

  BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.

  Baseline, Week 16, Week 24

• Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)

  The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.

  Week 16, Week 24

Secondary Outcomes (4)

• Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16

  Week 16

• Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score

  at Baseline and Weeks 4, 8, and 16

• Mean Number of Swollen or Tender Joints on the 28-Joint Count

  at Baseline and at Weeks 4, 8, 12 and 16

• Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24

  Week 20, Week 24

Study Arms (2)

Acthar Gel

EXPERIMENTAL

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks

Drug: Acthar Gel

Placebo Gel

PLACEBO COMPARATOR

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks

Drug: Placebo Gel

Interventions

Acthar Gel DRUG

1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)

Also known as: Repository corticotropin

Acthar Gel

Placebo Gel DRUG

1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Also known as: Matching placebo

Placebo Gel

Eligibility Criteria

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

You may qualify if:

• To be eligible to participate in this trial, a patient must:
• Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
• Have active SLE
• Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
• Have a documented history or screening result of
• positive antinuclear antibody (ANA), OR
• elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
• Have been on prednisone (or prednisone equivalent) before the screening visit:
• at least 8 weeks, and
• at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

You may not qualify if:

• A patient is not eligible to participate if he/she:
• Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
• Has active lupus nephritis
• Has active central nervous system (CNS) manifestations of SLE

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (39)

C.V. Mehta MD Medical Corporation

Hemet, California, 92543, United States

Location

Inland Rheumatology Clinical Trials

Upland, California, 91786, United States

Location

Center for Rheumatology Immunology and Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

San Marcus Research Clinic

Miami, Florida, 33015, United States

Location

Advanced Pharma CR

Miami, Florida, 33147, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

Office of George Timothy Kelly MD

Las Vegas, Nevada, 89128, United States

Location

NewYork-Presbyterian Columbia University Medical Center

New York, New York, 10032, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, 44130, United States

Location

Arthritis & Rheumatology Center of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

West Tennessee Physicians' Alliance

Jackson, Tennessee, 38305, United States

Location

Office of Ramesh C. Gupta, MD

Memphis, Tennessee, 38119, United States

Location

Accurate Clinical Research

Houston, Texas, 77034, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Aprillus Asistencia e Investigación

Buenos Aires, C1046AAQ, Argentina

Location

Consultorios Médicos Dr. Catalán Pellet

Buenos Aires, C1111AAL, Argentina

Location

Centro Medico Privado de Reumatología

San Miguel de Tucumán, T4000AXL, Argentina

Location

Biomedica Research Group

Santiago, 7500710, Chile

Location

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

IBIOMED Research Unit Aguascalientes

Aguascalientes, 20010, Mexico

Location

Centro Especializado en Investigación Clínica

Boca del Río, 94290, Mexico

Location

Phylasis Clinicas Research S de RL de CV

Cuautitlán Izcalli, 54769, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000, Mexico

Location

Unidad de Investigación de las Enfermedades Reumáticas

Mexico City, 06090, Mexico

Location

Centro Peninsular de Investigacion Clinica S.C.P.

Mérida, 97000, Mexico

Location

Köhler and Milstein Research

Mérida, 97070, Mexico

Location

Consultorio de Reumatología

México, 07760, Mexico

Location

Centro Integral de Reumatologia

México, 44160, Mexico

Location

Accelerium Clinical Research

Monterrey, 64000, Mexico

Location

Centro de Estudios Clínicos y Especialidades Médicas

Monterrey, 64620, Mexico

Location

SMIQ

Querétaro, 76090, Mexico

Location

Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC

San Luis Potosí City, 78213, Mexico

Location

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, 45030, Mexico

Location

Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion

Lima, Peru

Location

Clinica Vesalio

San Borja, 15036, Peru

Location

Hospital de Apoyo Maria Auxiliadora

San Juán de Miraflores, 15801, Peru

Location

Hospital Nacional Cayetano Heredia

San Martín de Porres, 15102, Peru

Location

Related Publications (4)

• Askanase AD, Wright D, Zhao E, Zhu J, Bilyk R, Furie RA. Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar(R) Gel) for Persistently Active Systemic Lupus Erythematosus. Rheumatol Ther. 2021 Dec;8(4):1871-1886. doi: 10.1007/s40744-021-00351-7. Epub 2021 Sep 3.

  PMID: 34478124 DERIVED

• Askanase AD, Wan GJ, Panaccio MP, Zhao E, Zhu J, Bilyk R, Furie RA. Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar(R) Gel) for Persistently Active Systemic Lupus Erythematosus. Rheumatol Ther. 2021 Mar;8(1):573-584. doi: 10.1007/s40744-021-00294-z. Epub 2021 Mar 9.

  PMID: 33687687 DERIVED

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

  PMID: 33687069 DERIVED

• Askanase AD, Zhao E, Zhu J, Bilyk R, Furie RA. Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Rheumatol Ther. 2020 Dec;7(4):893-908. doi: 10.1007/s40744-020-00236-1. Epub 2020 Sep 29.

  PMID: 32996096 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 3, 2016
• Study Start: December 16, 2016
• Primary Completion: July 31, 2019
• Study Completion: October 25, 2019
• Last Updated: August 20, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); AR (3); ME (15); CL (1); PE (4)