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Janus Kinase (JAK) Inhibitor

Dose Escalation Extension Group for Cutaneous Lichen Planus

Phase 2
Waitlist Available
Led By Aaron R Mangold, MD
Research Sponsored by Aaron R. Mangold
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 baseline, 2, 4, 8, 12, 16, 20, 32 weeks
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating a skin condition called Cutaneous Lichen Planus.

Eligible Conditions
  • Cutaneous Lichen Planus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2, 4, 8, 12, 16, 20, 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 4, 8, 12, 16, 20, 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physician Global Assessment (PGA) of skin overall response
Secondary outcome measures
Change in Pruritus Numerical Rating Scale (NRS)
Change in Skindex-16 assessment
Change in lesion count
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Escalation Extension GroupExperimental Treatment1 Intervention
Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 16 weeks
Group II: Cutaneous LPExperimental Treatment1 Intervention
Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib (LY3009104) 2 mg
2022
Completed Phase 2
~20
Baricitinib (LY3009104) 4 mg
2022
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Aaron R. MangoldLead Sponsor
2 Previous Clinical Trials
24 Total Patients Enrolled
Aaron R Mangold, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

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

Are there any similar investigations to the one being conducted with Baricitinib (LY3009104)?

"At this moment, 34 separate studies are being conducted to study the efficacy of Baricitinib (LY3009104). Of these, 17 trials are in Phase 3. The many trials for Baricitinib (LY3009104) originate from Pune, Maharashtra but can be found at 1439 different locations."

Answered by AI

Are we still able to add people to this experiment?

"Yes, the trial is still open and recruiting patients. According to the information on clinicaltrials.gov, the posting date was 1/11/2022 and there have been no updates since then. They are looking for a total of 12 participants at 1 site."

Answered by AI

For what medical conditions is Baricitinib (LY3009104) most often prescribed?

"Baricitinib (LY3009104) is an effective treatment for hospitalized patients with coronavirus disease 2019 (covid‑19) who are using extracorporeal membrane oxygenation."

Answered by AI

How many people can join this clinical trial at the very most?

"That is correct, the trial information on clinicaltrials.gov does show that recruitment is still open for this study. The posting date was 1/11/2022 and there have been no edits since then. They are looking to enroll 12 patients total from 1 location."

Answered by AI

Does Baricitinib (LY3009104) have a lot of reported side effects?

"While there is some evidence to support the safety of Baricitinib (LY3009104), it only received a 2 because, as a Phase 2 drug, no efficacy data has been collected yet."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Pennsylvania
How old are they?
65+
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Mayo Clinic in Arizona: < 24 hours
Typically responds via
Email
Phone Call
~4 spots leftby Mar 2025