Active not recruiting

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (Hair Loss)

I4V-MC-JAHO - ClinicalTrials.gov - NCT03570749

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata.
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 Participants With Severe or Very Severe Alopecia Areata (Hair Loss)

I4V-MC-JAHO - ClinicalTrials.gov - NCT03570749

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata.
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)

Participants must have severe or very severe alopecia areata (AA), as determined by all of the following: - current AA episode of more than 6 months' duration and hair loss encompassing at least half of the scalp - no spontaneous improvement in previous 6 months - current episode of severe to very severe alopecia areata of less than 8 years - current episode may be present for more than 8 years provided episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years

Participants must be male or nonpregnant, nonbreastfeeding female participants

Participants must NOT

Participants must not have primarily “diffuse” type of alopecia areata

Participants must not be currently experiencing other forms of alopecia or any other health problem that would make it difficult to see how the study drug is working on alopecia areata

Participants must not have been treated with a Janus kinase (JAK) inhibitor

Participants must not have topical applied to scalp within 4 weeks of randomization

Participants must not have oral within 8 weeks of randomization

Participants must not have previous inadequate response to oral JAKi (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

725

Trial Dates

September 2018 - June 2024

Trial Phase

1

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)

Participants must have severe or very severe alopecia areata (AA), as determined by all of the following: - current AA episode of more than 6 months' duration and hair loss encompassing at least half of the scalp - no spontaneous improvement in previous 6 months - current episode of severe to very severe alopecia areata of less than 8 years - current episode may be present for more than 8 years provided episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years

Participants must be male or nonpregnant, nonbreastfeeding female participants

Participants must NOT

Participants must not have primarily “diffuse” type of alopecia areata

Participants must not be currently experiencing other forms of alopecia or any other health problem that would make it difficult to see how the study drug is working on alopecia areata

Participants must not have been treated with a Janus kinase (JAK) inhibitor

Participants must not have topical applied to scalp within 4 weeks of randomization

Participants must not have oral within 8 weeks of randomization

Participants must not have previous inadequate response to oral JAKi (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

725

Trial Dates

September 2018 - June 2024

Trial Phase

1

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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?