Trial · NCT03570749
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
NCT03570749, Phase 2, Phase 3, Completed, Eli Lilly and Company; results first posted 2025-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata. Trials, record NCT03570749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03570749
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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 Participants With Severe or Very Severe Alopecia Areata
- NCT number
- NCT03570749
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 784 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alopecia Areata
- Interventions
- Baricitinib, Placebo
- First posted
- 2018-06-27
- Last updated
- 2026-04-16
- Results first posted
- 2025-10-01
Source ClinicalTrials.gov
Registered outcomes17
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 - Phase 3 | 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. |
| Primary | Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum | Baseline, Week 52 | 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 - Phase 3 | Baseline, 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. 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 SALT (SALT50) - Phase 3 | 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. |
| Secondary | Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3 | 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) - Phase 3 | 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) - Phase 3 | 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 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 - Phase 3 | Week 36 | PRO is an assessment of the participant'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 | 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) - Phase 3 | 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) - Phase 3 | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes11
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 - Phase 3 | Week 36 | All randomized participants in Phase 3 portion, in both Stages 1 and 2. | 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 - Phase 3 | Week 36 | All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline PRO for scalp hair assessment of ≥ 3. | percentage of participants | NUMBER |
| SECONDARY | 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) - Phase 3 | Week 36 | All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline PRO measure for EB ≥ 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) - Phase 3 | Week 36 | All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline PRO measure for EL ≥ 2. | percentage of participants | NUMBER |
| 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) - Phase 3 | Week 36 | All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline ClinRO measure for EB Hair Loss ≥ 2. | percentage of participants | NUMBER |
| SECONDARY | 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) - Phase 3 | Week 36 | All randomized participants in Phase 3 portion, in both Stages 1 and 2 with baseline ClinRO measure for EL hair loss ≥ 2. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in SALT Score - Phase 3 | Baseline, Week 36 | All randomized participants in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and least one postbaseline measures. A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 | Week 12 | All randomized participants in Phase 3 portion, in both Stages 1 and 2. | percentage of participants | NUMBER |
| SECONDARY | Time for Participants to Achieve SALT ≤ 20 | Week 52 | |||
| SECONDARY | Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3 | Baseline, Week 36 | All randomized participants in Phase 3 portion, Stages 1 and 2 with a nonmissing baseline and at least one postbaseline measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group30
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 - Phase 3 | Placebo Phase 3 | 5.3 | 95% Confidence Interval 2.9 to 9.5 | percentage of participants | |
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 | 2 mg Baricitinib Phase 3 | 21.7 | 95% Confidence Interval 16.4 to 28.2 | percentage of participants | |
| Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3 | 4 mg Baricitinib Phase 3 | 35.2 | 95% Confidence Interval 29.9 to 41.0 | 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 - Phase 3 | Placebo Phase 3 | 5.0 | 95% Confidence Interval 2.6 to 9.2 | 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 - Phase 3 | 2 mg Baricitinib Phase 3 | 16.0 | 95% Confidence Interval 11.3 to 22.2 | 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 - Phase 3 | 4 mg Baricitinib Phase 3 | 33.1 | 95% Confidence Interval 27.8 to 38.9 | percentage of participants | |
| 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) - Phase 3 | Placebo Phase 3 | 3.1 | 95% Confidence Interval 1.2 to 7.6 | percentage of participants | |
| 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) - Phase 3 | 2 mg Baricitinib Phase 3 | 16.3 | 95% Confidence Interval 11.1 to 23.3 | percentage of participants | |
| 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) - Phase 3 | 4 mg Baricitinib Phase 3 | 32.1 | 95% Confidence Interval 25.7 to 39.1 | percentage of participants | |
| 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) - Phase 3 | Placebo Phase 3 | 2.0 | 95% Confidence Interval 0.6 to 7.0 | percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Phase 2 | 28 | |
| Overall Study | STARTED | 1 Milligram (mg) Baricitinib Phase 2 | 28 | |
| Overall Study | STARTED | 2 mg Baricitinib Phase 2 | 27 | |
| Overall Study | STARTED | 4 mg Baricitinib Phase 2 | 27 | |
| Overall Study | STARTED | Placebo Phase 3 | 189 | |
| Overall Study | STARTED | 2 mg Baricitinib Phase 3 | 184 | |
| Overall Study | STARTED | 4 mg Baricitinib Phase 3 | 281 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo Phase 2 | 28 | |
| Overall Study | Received at Least One Dose of Study Drug | 1 Milligram (mg) Baricitinib Phase 2 | 28 | |
| Overall Study | Received at Least One Dose of Study Drug | 2 mg Baricitinib Phase 2 | 27 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events238
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 | Neutropenia | Blood and lymphatic system disorders | Placebo Phase 2 | 0 | 28 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 1 mg Baricitinib Phase 2 | 0 | 28 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 2 mg Baricitinib Phase 2 | 1 | 27 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | 4 mg Baricitinib Phase 2 | 2 | 27 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo Phase 3 | 0 | 189 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 2 mg Baricitinib Phase 3 | 0 | 183 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | 4 mg Baricitinib Phase 3 | 0 | 280 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo Phase 2 | 0 | 28 | 0 |
| other | Nausea | Gastrointestinal disorders | 1 mg Baricitinib Phase 2 | 1 | 28 | 1 |
| other | Nausea | Gastrointestinal disorders | 2 mg Baricitinib Phase 2 | 2 | 27 | 2 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Phase 2 | 0 | 28 |
| Total, all-cause mortality | 1 mg Baricitinib Phase 2 | 0 | 28 |
| Total, all-cause mortality | 2 mg Baricitinib Phase 2 | 0 | 27 |
| Total, all-cause mortality | 4 mg Baricitinib Phase 2 | 0 | 27 |
| Total, all-cause mortality | Placebo Phase 3 | 0 | 189 |
| Total, all-cause mortality | 2 mg Baricitinib Phase 3 | 0 | 183 |
| Total, all-cause mortality | 4 mg Baricitinib Phase 3 | 0 | 280 |
| Total, other adverse events | Placebo Phase 2 | 11 | 28 |
| Total, other adverse events | 1 mg Baricitinib Phase 2 | 8 | 28 |
| Total, other adverse events | 2 mg Baricitinib Phase 2 | 16 | 27 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers10
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.
GET https://conductscience.org/api/trials/v1/NCT03570749
GET https://conductscience.org/api/trials/v1/NCT03570749/results?page=2