Active not recruiting

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

I4V-MC-JAIR - ClinicalTrials.gov - NCT03899259

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
How long will I be in the trial?
The study will last about 104 weeks and may include up to 18 visits.
Email
Active not recruiting

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

I4V-MC-JAIR - ClinicalTrials.gov - NCT03899259

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
How long will I be in the trial?
The study will last about 104 weeks and may include up to 18 visits.
Email

Key Requirements

Age :

18-70

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18-70

Sex

All

Participants must

Participants must be at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent

Participants must have severe or very severe AA, as determined by all of the following: - Current AA episode of more than 6 months’ duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline - no spontaneous improvement over the past 6 months - current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe 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

Participant must be male or nonpregnant, nonbreastfeeding female participants

Participants must NOT

Participants must not have primarily “diffuse” type of AA

Participants must not be currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA

Participants must not have been previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment)

Trial Summary

Conditions the trial is for

Alopecia Areata (Hair Loss)

What the trial is testing?

Baricitinib, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

476

Trial Dates

July 2019 - May 2024

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18-70

Sex

All

Participants must

Participants must be at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent

Participants must have severe or very severe AA, as determined by all of the following: - Current AA episode of more than 6 months’ duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline - no spontaneous improvement over the past 6 months - current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe 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

Participant must be male or nonpregnant, nonbreastfeeding female participants

Participants must NOT

Participants must not have primarily “diffuse” type of AA

Participants must not be currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA

Participants must not have been previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment)

Trial Summary

Conditions the trial is for

Alopecia Areata (Hair Loss)

What the trial is testing?

Baricitinib, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

476

Trial Dates

July 2019 - May 2024

Trial Phase

3

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Trial Locations

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Alopecia Areata (Hair Loss) Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?