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Baricitinib for Alopecia Areata

University of Miami, Miami, FL
Alopecia AreataBaricitinib - Drug
Eligibility
18 - 70
All Sexes

Study Summary

This trial will help determine if baricitinib is an effective treatment for severe or very severe alopecia areata, and what the best dosage is.

Eligible Conditions
  • Alopecia Areata

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

Similar Trials

1
SADBE 5%
1
Ritlecitinib 20 mg
1
Daxdilimab

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Week 36

Baseline through Week 36
Time for Participants to Achieve SALT ≤ 20
Baseline, Week 36
Percent Change from Baseline in SALT Score
Week 12
Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
Week 36
Mean Change From Baseline in HADS Depression Score
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score
Percentage of Participants Achieving ClinRO Measure for Eye Lash (EL) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)
Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for EyeBrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from Baseline (Among Participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline)
Percentage of Participants Achieving PRO Measure for EB 0 or 1 with ≥2-point improvement from Baseline (Among Participants with PRO Measure for EB ≥2 at Baseline)
Percentage of Participants Achieving PRO Measure for EB 0 or 1 with ≥2-point improvement from Baseline (Among Participants with Patient Reported Outcome (PRO) Measure for EB ≥2 at Baseline)
Percentage of Participants Achieving PRO Measure for EL 0 or 1 with ≥2-point improvement from Baseline (Among Participants with PRO Measure EL ≥2 at Baseline)
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 with a ≥2-point improvement from Baseline among participants with a score of ≥3 at Baseline

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
SADBE 5%
1
Ritlecitinib 20 mg
2
Daxdilimab

Side Effects for

Adalimumab Follow-up
10%Upper respiratory tract infection
6%Ovarian cyst
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01710358) in the Adalimumab Follow-up ARM group. Side effects include: Upper respiratory tract infection with 10%, Ovarian cyst with 6%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4 Treatment Groups

Open-Label Addenda Baricitinib High Dose
1 of 4
Baricitinib Low Dose
1 of 4
Baricitinib High Dose
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

824 Total Participants · 4 Treatment Groups

Primary Treatment: Baricitinib · Has Placebo Group · Phase 2 & 3

Open-Label Addenda Baricitinib High Dose
Drug
Experimental Group · 1 Intervention: Baricitinib · Intervention Types: Drug
Baricitinib Low DoseExperimental Group · 2 Interventions: Baricitinib, Placebo · Intervention Types: Drug, Drug
Baricitinib High DoseExperimental Group · 2 Interventions: Baricitinib, Placebo · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 36

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,500 Previous Clinical Trials
3,154,491 Total Patients Enrolled
2 Trials studying Alopecia Areata
1,141 Patients Enrolled for Alopecia Areata
Incyte CorporationIndustry Sponsor
331 Previous Clinical Trials
47,333 Total Patients Enrolled
2 Trials studying Alopecia Areata
636 Patients Enrolled for Alopecia Areata
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,281 Previous Clinical Trials
381,010 Total Patients Enrolled
1 Trials studying Alopecia Areata
595 Patients Enrolled for Alopecia Areata

Eligibility Criteria

Age 18 - 70 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your condition has not improved on its own in the past 6 months.

Who else is applying?

What state do they live in?
Texas50.0%
Pennsylvania12.5%
Massachusetts12.5%
Other25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Medaphase Inc20.0%
ActivMed Practices and Research20.0%
Penn State Univ. Milton S. Hershey Medical Center20.0%
Other40.0%
What portion of applicants met pre-screening criteria?
Met criteria62.5%
Did not meet criteria37.5%
References

Frequently Asked Questions

For what illnesses is Baricitinib commonly prescribed?

"Baricitinib has shown efficacy in treating patients that are hospitalized with coronavirus disease 2019 (covid‑19) and require extracorporeal membrane oxygenation." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this clinical trial for participants?

"This trial is no longer recruiting participants. It was originally posted on September 24th, 2018 and last updated February 2nd, 2022. However, there are 93 other trials for alopecia areata and 34 for Baricitinib that are still looking for patients to enroll." - Anonymous Online Contributor

Unverified Answer

What insights have been gleaned from prior research on Baricitinib?

"University of Nebraska Medical Center first researched baricitinib in 2007 and, since then, 18310 similar studies have been completed. As of now, there are 34 ongoing clinical trials with a large portion taking place in New Haven, Connecticut." - Anonymous Online Contributor

Unverified Answer

To whom does this experiment offer the most potential benefit?

"This clinical trial is seeking 764 participants that suffer from alopecia areata. The study has the following age requirements: 18-70 for males and 18-70 for females. Additionally, applicants must meet the following other conditions: Current episode of severe or very severe AA of less than 8 years (participants who have severe or verysevere AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years), current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured" - Anonymous Online Contributor

Unverified Answer

Are elderly patients welcome in this clinical trial?

"All individuals above the age of 18 and under 70 are eligible to participate in this trial." - Anonymous Online Contributor

Unverified Answer

Is this study also being conducted in other countries besides the United States?

"Multiple locations across the United States are participating in this clinical trial, including but not limited to Yale University School of Medicine in New Haven, Connecticut and California Dermatology & Clinical Research Institute in Encinitas, Kentucky." - Anonymous Online Contributor

Unverified Answer

How many people have been selected to participate in this trial?

"Unfortunately, this particular study is not currently admitting patients. Although, it was last updated on February 2nd, 2022. There are 93 other studies for alopecia areata and 34 for Baricitinib that are actively recruiting individuals right now." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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