A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03843125

2017-005028-11 (EudraCT Number)

16832

I4V-MC-JAIM (Other Identifier)

Details and patient eligibility

About

The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

Enrollment: 1,147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,147 participants in 4 patient groups

2 mg Baricitinib

Experimental group

Description:

Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).

Treatment:

Drug: Placebo

Drug: Baricitinib

4 mg Baricitinib

Experimental group

Description:

Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

Treatment:

Drug: Placebo

Drug: Baricitinib

Placebo to 2 mg Baricitinib

Experimental group

Description:

Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.

Treatment:

Drug: Placebo

Drug: Baricitinib

Placebo to 4 mg Baricitinib

Experimental group

Description:

Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.

Treatment:

Drug: Placebo

Drug: Baricitinib