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Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

NCT02953821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2020-08-20

Study results available
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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

Interventions

DRUG

Acthar Gel

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

DRUG

Placebo Gel

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2019-07-31
Completion
2019-10-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Chile
  • Mexico
  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953821 on ClinicalTrials.gov