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Janus Kinase (JAK) Inhibitor

Baricitinib for Dermatomyositis

Phase 2
Waitlist Available
Led By Kwanghoon Han, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks and 24 weeks
Awards & highlights

Study Summary

This trial is testing a new drug for people with cutaneous DM who haven't responded well to other treatments. The drug is taken daily for 8 weeks, and then the dose is increased for 16 more weeks. There are follow-up visits at various times to check on the person's progress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Adverse event
Cutaneous Disease Activity Severity Index (CDASI) activity score
Dermatology Life Quality Index (DLQI)
+2 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
10%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Treatment B
Adalimumab Treatment A
Adalimumab Treatment B
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Follow-up
BaricitinibTreatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue

Trial Design

1Treatment groups
Experimental Treatment
Group I: BarcitinibExperimental Treatment1 Intervention
All subjects will initially receive baricitinib 2mg daily for 8 weeks. If no unexpected serious adverse events related to baricitinib have occurred during the first 8 weeks of treatment in the opinion of the investigator, the dose will be increased to 4 mg daily for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,351 Total Patients Enrolled
Kwanghoon Han, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently able to sign up for this clinical trial?

"The clinical trial mentioned is not actively recruiting patients at this time. It was posted on May 1st, 2022 and last updated April 29th, 2022. There are 24 other trials that are currently active."

Answered by AI

Are there any documented risks of taking Baricitinib?

"Although there is some evidence of its safety, baricitinib only received a 2 because there is no data currently supporting efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Baricitinib for Cutaneous Dermatomyositis
Kwanghoon (Bobby) Han 2022. "Baricitinib for Cutaneous Dermatomyositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361109.
~0 spots leftby Apr 2025
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