Trial · NCT05188521
Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
NCT05188521, Phase 2, Completed, Aaron R. Mangold; results first posted 2024-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus. Trials, record NCT05188521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05188521
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
- NCT number
- NCT05188521
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Aaron R. Mangold
- Conditions
- Cutaneous Lichen Planus
- Interventions
- Baricitinib (LY3009104) 2 mg, Baricitinib (LY3009104) 4 mg
- First posted
- 2022-01-12
- Last updated
- 2024-06-11
- Results first posted
- 2024-06-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Physician Global Assessment (PGA) of Skin Overall Response | Week 16 | Measured by Physician Global Assessment (PGA) of skin by grade. The assessment ranges from Grade 0 (completely clear with no evidence of disease; 100% improvement) to Grade 6 (worse than at baseline evaluation by ≥25%; more progressive disease). |
| Secondary | Change in Modified CAILS Score of the Cutaneous Index Treatment | Baseline, Week 16 | Measured by Modified CAILS-Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS). The area of the lesion is measured with digital planimetry. Lesion size by square centimeter is graded on a scale of 0 to 18, where 0 is no measurable area and 18 is greater than 300 centimeters. The higher the score the larger the lesion. |
| Secondary | Change in Modified CAILS Score of the Cutaneous Index Treatment | Week 16, Week 28 | Measured by Modified CAILS-Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS). The area of the lesion is measured with digital planimetry. Lesion size by square centimeter is graded on a scale of 0 to 18, where 0 is no measurable area and 18 is greater than 300 centimeters. The higher the score the larger the lesion. |
| Secondary | Change in Skin Lesion Count | Baseline, Week 16 | Change in the number of subject's skin lesions from baseline to Week 16. |
| Secondary | Change in Skin Lesion Count | Week 16, Week 28 | Change in the number of subject's skin lesions from Week 16 to Week 28. |
| Secondary | Change in Pruritus Numerical Rating Scale (NRS) | Baseline, Week 16 | The Pruritus NRS is self-reported single question that asks "how severe itching has been over the last 24 hours". The response uses a scale of 0 (no itching) to 10 (severe itching). The higher the score, the worse the itching. |
| Secondary | Change in Pruritus Numerical Rating Scale (NRS) | Week 16, Week 28 | The Pruritus NRS is self-reported single question that asks "how severe itching has been over the last 24 hours". The response uses a scale of 0 (no itching) to 10 (severe itching). The higher the score, the worse the itching. |
| Secondary | Change in Overall Skindex-16 Assessment | Baseline, Week 16 | This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life. |
| Secondary | Change in Overall Skindex-16 Assessment | Week 16, Week 28 | This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Physician Global Assessment (PGA) of Skin Overall Response | Week 16 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Modified CAILS Score of the Cutaneous Index Treatment | Baseline, Week 16 | score on a scale | MEAN | |
| SECONDARY | Change in Modified CAILS Score of the Cutaneous Index Treatment | Week 16, Week 28 | score on a scale | MEAN | |
| SECONDARY | Change in Skin Lesion Count | Baseline, Week 16 | number of skin lesions | MEAN | |
| SECONDARY | Change in Skin Lesion Count | Week 16, Week 28 | number of skin lesions | MEAN | |
| SECONDARY | Change in Pruritus Numerical Rating Scale (NRS) | Baseline, Week 16 | score on a scale | MEAN | |
| SECONDARY | Change in Pruritus Numerical Rating Scale (NRS) | Week 16, Week 28 | score on a scale | MEAN | |
| SECONDARY | Change in Overall Skindex-16 Assessment | Baseline, Week 16 | score on a scale | MEAN | |
| SECONDARY | Change in Overall Skindex-16 Assessment | Week 16, Week 28 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 0 | 5 | Participants | |
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 1 | 5 | Participants | |
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 2 | 0 | Participants | |
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 3 | 0 | Participants | |
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 4 | 1 | Participants | |
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 5 | 0 | Participants | |
| Physician Global Assessment (PGA) of Skin Overall Response | Cutaneous LP | Grade 6 | 0 | Participants | |
| Change in Modified CAILS Score of the Cutaneous Index Treatment | Cutaneous LP | -10.6 | Standard Deviation 2.9 | score on a scale | |
| Change in Modified CAILS Score of the Cutaneous Index Treatment | Dose Escalation Extension Group | -1.1 | Standard Deviation 4.3 | score on a scale | |
| Change in Skin Lesion Count | Cutaneous LP | -134.8 | Standard Deviation 157.0 | number of skin lesions |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baricitinib 2mg Initial Study | STARTED | Cutaneous LP | 12 | |
| Baricitinib 2mg Initial Study | STARTED | Dose Escalation Extension Group | 0 | |
| Baricitinib 2mg Initial Study | COMPLETED | Cutaneous LP | 11 | |
| Baricitinib 2mg Initial Study | COMPLETED | Dose Escalation Extension Group | 0 | |
| Baricitinib 2mg Initial Study | NOT COMPLETED | Cutaneous LP | 1 | |
| Baricitinib 2mg Initial Study | NOT COMPLETED | Dose Escalation Extension Group | 0 | |
| Baricitinib 4mg Extension Study | STARTED | Cutaneous LP | 0 | |
| Baricitinib 4mg Extension Study | STARTED | Dose Escalation Extension Group | 5 | |
| Baricitinib 4mg Extension Study | COMPLETED | Cutaneous LP | 0 | |
| Baricitinib 4mg Extension Study | COMPLETED | Dose Escalation Extension Group | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events34
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 | Foot/leg pain/cramps | General disorders | Cutaneous LP | 2 | 12 | 2 |
| other | Foot/leg pain/cramps | General disorders | Dose Escalation Extension Group | 1 | 5 | 1 |
| other | Headache | General disorders | Cutaneous LP | 2 | 12 | 2 |
| other | Headache | General disorders | Dose Escalation Extension Group | 0 | 5 | 0 |
| other | Constipation | General disorders | Cutaneous LP | 0 | 12 | 0 |
| other | Constipation | General disorders | Dose Escalation Extension Group | 1 | 5 | 2 |
| other | Night Sweats | General disorders | Cutaneous LP | 0 | 12 | 0 |
| other | Night Sweats | General disorders | Dose Escalation Extension Group | 1 | 5 | 1 |
| other | Cold symptoms | General disorders | Cutaneous LP | 1 | 12 | 1 |
| other | Cold symptoms | General disorders | Dose Escalation Extension Group | 1 | 5 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cutaneous LP | 0 | 12 |
| Total, all-cause mortality | Dose Escalation Extension Group | 0 | 5 |
| Total, other adverse events | Cutaneous LP | 8 | 12 |
| Total, other adverse events | Dose Escalation Extension Group | 4 | 5 |
| Total, serious adverse events | Cutaneous LP | 1 | 12 |
| Total, serious adverse events | Dose Escalation Extension Group | 0 | 5 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cutaneous LP vs Dose Escalation Extension Group: deaths from any cause | Trial comparisons |
| Cutaneous LP vs Dose Escalation Extension Group: serious adverse events | Trial comparisons |
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/NCT05188521
GET https://conductscience.org/api/trials/v1/NCT05188521/events?page=2