JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult IIM

Sponsor
University of Manchester
Study ID
NCT04208464
Phase
PHASE2
Status
Completed

Conditions

  • Idiopathic Inflammatory Myopathies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    4mg daily for 24 weeks from baseline
  • Baricitinib — DRUG
    4mg daily for 24 weeks starting after a 12-week treatment delay from baseline

Study Details

This study aims to investigate the clinical efficacy of baricitinib in patients with adult idiopathic inflammatory myositis (IIM). Half of the patients enrolled onto the study will receive 24 weeks of baricitinib from the baseline visit with a 12 week follow-up period. The other half of patients will receive 24 weeks of barcitinib treatment after an initial 12-week delay with a 4 week follow up period for safety.

Key Dates

Start date
Oct 7, 2021
Status verified
Oct 2023
Primary completion
Sep 25, 2023
Completion
Sep 25, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate-start arm
    Participants will receive 4mg baracitinib daily for 24 weeks from the baseline visit in week 0. After treatment participants will be followed up for 12 weeks.
  • Experimental: Delayed-start arm
    After the baseline visit in week 0, participants will wait for a 12 week treatment delay and will then receive 4mg baracitinib daily from week 12-week 36 (i.e. for 24 weeks). After treatment participants will be followed up for 4 weeks for safety.

Primary Outcome Measure

Assess the clinical response across treatment arms after 24 weeks of active treatment. [ Time Frame: Immediate-start arm: 24 weeks after baseline visit; Delayed-start arm: 36 weeks after baseline visit ]

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