NCT04208464

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

A Randomised, Phase IIa Treatment Delayed-start Trial of the Oral JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult Idiopathic Inflammatory Myopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Potential participants will attend a screening visit to confirm their eligibility to participate in the trial. Once eligibility is confirmed the participant will be randomised to receive 24 weeks of baracitinib from the baseline visit with 12 weeks of follow up or receive 24 weeks of baracitinib after a delayed-start of 12 weeks from the baseline visit. Participants will attend study visits every 4 weeks starting at the baseline visit at week 0. At each visit data will be collected about the following: 1. Muscle function 2. Signs of disease activity 3. Vital signs 4. Physical examination 5. A blood test to check blood count, liver and kidney function and markers of inflammation for safety purposes. 6. Participant reported assessment of how disease disease is progressing. In addition the following data will be collected at week 0, week 12, week 24 and week 36: 1. Signs of disease damage 2. Blood and urine sample collection for biomarker analysis 3. Additional muscle function and disease activity assessments 4. Participant reported assessment of how disease affects their day-to-day life.

Conditions

• Idiopathic Inflammatory Myopathies

Interventions

Type	Name	Description
DRUG	Baricitinib	4mg daily for 24 weeks from baseline
DRUG	Baricitinib	4mg daily for 24 weeks starting after a 12-week treatment delay from baseline

Timeline

• Start date: 2021-10-07
• Primary completion: 2023-09-25
• Completion: 2023-09-25
• First posted: 2019-12-23
• Last updated: 2023-10-18

Locations

1 site across 1 country: United Kingdom