I4V-MC-JAIR - ClinicalTrials.gov - NCT03899259
I4V-MC-JAIR - ClinicalTrials.gov - NCT03899259
Key Requirements
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.
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
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.
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
Trial Locations
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