Trial · NCT03899259
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
NCT03899259, Phase 3, Completed, Eli Lilly and Company; results first posted 2024-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata. Trials, record NCT03899259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03899259
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
- NCT number
- NCT03899259
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 606 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alopecia Areata
- Interventions
- Baricitinib, Placebo
- First posted
- 2019-04-02
- Last updated
- 2026-04-07
- Results first posted
- 2024-05-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | Week 36 | The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. |
| Secondary | Percent Change From Baseline in SALT Score at Week 36 | Baseline, Week 36 | SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model. |
| Secondary | Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | Week 12 | SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. SALT50 indicates at least a 50 % improvement from baseline in the SALT score. |
| Secondary | 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 | Week 36 | PRO is an assessment of the particpant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair). |
| Secondary | Time for Participants to Achieve SALT ≤ 20 at Week 36. | Week 36 | The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure. |
| Secondary | 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) | Week 36 | ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB. |
| Secondary | Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline) | Week 36 | ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL. |
| Secondary | Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline) | Week 36 | PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs. |
| Secondary | 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) | Week 36 | PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair. |
| Secondary | Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | Baseline, Week 36 | Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | Week 36 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in SALT Score at Week 36 | Baseline, Week 36 | All randomized participants with nonmissing baseline and at least one postbaseline measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | Week 12 | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | 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 | Week 36 | All randomized participants with baseline PRO for scalp hair assessment score of ≥ 3. | percentage of participants | NUMBER |
| SECONDARY | Time for Participants to Achieve SALT ≤ 20 | Week 52 | |||
| SECONDARY | 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) | Week 36 | All randomized participants with baseline ClinRO measure for EB hair loss ≥ 2. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline) | Week 36 | All randomized participants with baseline ClinRO measure for EL hair loss ≥ 2. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline) | Week 36 | All randomized participants with baseline PRO measures for EB hair loss ≥2. | percentage of participants | NUMBER |
| SECONDARY | 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) | Week 36 | All randomized participants with baseline PRO Measure EL hair loss ≥2. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score | Baseline, Week 36 | All randomized participants with baseline and at least one postbaseline Skindex-16 AA Symptoms Domain Score. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | Placebo | 2.6 | 95% Confidence Interval 1.0 to 6.4 | percentage of participants | |
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 2 mg Baricitinib | 17.3 | 95% Confidence Interval 12.2 to 24.0 | percentage of participants | |
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 | 4 mg Baricitinib | 32.5 | 95% Confidence Interval 26.8 to 38.7 | percentage of participants | |
| Percent Change From Baseline in SALT Score at Week 36 | Placebo | -2.96 | Standard Error 2.723 | percentage of change | |
| Percent Change From Baseline in SALT Score at Week 36 | 2 mg Baricitinib | -28.21 | Standard Error 2.770 | percentage of change | |
| Percent Change From Baseline in SALT Score at Week 36 | 4 mg Baricitinib | -47.45 | Standard Error 2.229 | percentage of change | |
| Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | Placebo | 2.6 | 95% Confidence Interval 1.0 to 6.4 | percentage of participants | |
| Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 2 mg Baricitinib | 10.9 | 95% Confidence Interval 6.9 to 16.8 | percentage of participants | |
| Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) | 4 mg Baricitinib | 23.5 | 95% Confidence Interval 18.5 to 29.3 | percentage of participants | |
| 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 | Placebo | 4.0 | 95% Confidence Interval 1.8 to 8.4 | percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 156 | |
| Overall Study | STARTED | 2 mg Baricitinib | 156 | |
| Overall Study | STARTED | 4 mg Baricitinib | 234 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 155 | |
| Overall Study | Received at Least One Dose of Study Drug | 2 mg Baricitinib | 156 | |
| Overall Study | Received at Least One Dose of Study Drug | 4 mg Baricitinib | 234 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | 2 mg Baricitinib | 0 | |
| Overall Study | COMPLETED | 4 mg Baricitinib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 156 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 154 | 7 |
| other | Nasopharyngitis | Infections and infestations | 2 mg Baricitinib | 2 | 155 | 3 |
| other | Nasopharyngitis | Infections and infestations | 4 mg Baricitinib | 15 | 233 | 19 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 11 | 154 | 12 |
| other | Upper respiratory tract infection | Infections and infestations | 2 mg Baricitinib | 12 | 155 | 13 |
| other | Upper respiratory tract infection | Infections and infestations | 4 mg Baricitinib | 15 | 233 | 16 |
| other | Urinary tract infection | Infections and infestations | Placebo | 2 | 154 | 2 |
| other | Urinary tract infection | Infections and infestations | 2 mg Baricitinib | 12 | 155 | 14 |
| other | Urinary tract infection | Infections and infestations | 4 mg Baricitinib | 11 | 233 | 14 |
| other | Headache | Nervous system disorders | Placebo | 10 | 154 | 11 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 154 |
| Total, all-cause mortality | 2 mg Baricitinib | 0 | 155 |
| Total, all-cause mortality | 4 mg Baricitinib | 0 | 233 |
| Total, other adverse events | Placebo | 28 | 154 |
| Total, other adverse events | 2 mg Baricitinib | 39 | 155 |
| Total, other adverse events | 4 mg Baricitinib | 63 | 233 |
| Total, serious adverse events | Placebo | 3 | 154 |
| Total, serious adverse events | 2 mg Baricitinib | 4 | 155 |
| Total, serious adverse events | 4 mg Baricitinib | 8 | 233 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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