Cutaneous Lichen PlanusPhase 2NCT05188521
Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
A Phase 2 study testing Baricitinib (LY3009104) 2 mg and Baricitinib (LY3009104) 4 mg in people with Cutaneous Lichen Planus, run by Aaron R. Mangold at 1 site in United States.
Trial summary
This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lichen Planus
- What is being tested?
- Baricitinib (LY3009104) 2 mg and Baricitinib (LY3009104) 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 17 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation
- Both men and women must be at least 18 years of age at the time of screening
- Subjects must have clinical and histological features of LP
- LP requiring systemic treatment
- Subjects must have treatment naïve cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP. Failure of prior therapy: topical treatment, systemic immunosuppressant, oral metronidazole, oral sulfasalazine, oral retinoid
Who cannot join
- On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy
- Known hypersensitivity or other adverse reaction to Baricitinib (LY3009104)
- Variants of LP deemed by the investigators to be inappropriate for Baricitinib (LY3009104) including but not limited to:
- o Drug-induced LP: Predominant non-cutaneous variants of LP, note that individuals can have disease in non-cutaneous areas; however, they must also have cutaneous disease Lichen Planopilaris or Oral Lichen planus
- Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test)
- Women of childbearing potential [Post-menopausal or not of child-bearing potential is defined by 1 year of natural (spontaneous) amenorrhea or surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. Oophorectomy alone must be confirmed by follow up hormone level assessment to be considered not of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception which includes:
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- Total abstinence (Periodic abstinence and withdrawal are not acceptable methods of contraception)
- Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. Oophorectomy alone requires follow up hormone level assessment for fertility.
- Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
- Barrier methods of contraception: condom or occlusive cap.
- Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure <1%). (The dose of the contraceptive should be stable for 3 months)
- Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of the benefit of Baricitinib (LY3009104)
- Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
- Moderate-to-severe renal impairment including patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2
- Active systemic infections during the 2 weeks prior to randomization (common cold viruses excluded) or any infection that reoccurs on a regular basis
- Current severe progressive or uncontrolled disease which the investigator renders the subject unsuitable for the trial or puts the subject at increased risk
- Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the patient.
- Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of recurrent (≥ 2) VTE (DVT/PE).
- Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years prior to randomization.
- Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
- Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
- ALT or AST >2 x upper limits of normal (ULN); alkaline phosphatase (ALP) ≥2 x ULN; total bilirubin ≥1.5 x ULN; hemoglobin <10 g/dL (100.0 g/L); total white blood cell count <3000 cells/μL (<3.00 x 103/μL or <3.00 billion/L); neutropenia (absolute neutrophil count [ANC] <1500 cells/μL) (<1.50 x 103/μL or <1.50 billion/L); lymphopenia (lymphocyte count <1000 cells/μL) (<1.00 x 103/μL or <1.00 billion/L); thrombocytopenia (platelets <100,000 cells/μL) (<100 x 103/μL or <100 billion/L) Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled in the study but will require additional HBV DNA monitoring during the study.
- Have a positive test for hepatitis B virus (HBV) defined as positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA). Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled in the study but will require additional HBV DNA monitoring during the study.
- Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive).
- Note: Patients who have documented anti-HCV treatment for a past HCV infection AND are HCV RNA-negative may be enrolled in the study.
- Have evidence of HIV infection and/or positive HIV antibodies.
- Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
- Have evidence of active TB or latent TB
- Have evidence of active TB, defined in this study as the following:
- Positive purified protein derivative (PPD) test (≥5 mm induration between approximately 2 and 3 days after application, regardless of vaccination history), medical history, clinical features, and abnormal chest x-ray at screening.
- QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. Patients are excluded from the study if the test is not negative and there is clinical evidence of active TB. Exception: patients with a history of active TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, have no clinical features of active TB, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria met. Such patients would not be required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT®.TB test but must have a chest x-ray at screening (i.e., chest imaging performed within the past 6 months will not be accepted).
- Have evidence of untreated/inadequately or inappropriately treated latent TB, defined in this study as the following:
- Positive PPD test, no clinical features consistent with active TB, and a chest x-ray with no evidence of active TB at screening; or
- If the PPD test is positive and the patient has no medical history or chest x-ray findings consistent with active TB, the patient may have a QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines). If the test results are not negative, the patient will be considered to have latent TB (for purposes of this study); or
- QuantiFERON®-TB Gold test or T- SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. If the test results are positive, the patient will be considered to have latent TB. If the test is not negative, the test may be repeated once within approximately 2 weeks of the initial value. If the repeat test results are again not negative, the patient will be considered to have latent TB (for purposes of this study).
- Have been exposed to a live vaccine within 12 weeks of randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination).
- Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood during the course of the study.
- Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana).
Trial locations and contacts
1 site in 1 country.
About this study
This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).
- Conditions
- Cutaneous Lichen Planus
- Being tested
- Baricitinib (LY3009104) 2 mg, Baricitinib (LY3009104) 4 mg
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib (LY3009104) 2 mgDrug
2 mg orally administered once daily for 16 weeks
Baricitinib (LY3009104) 4 mgDrug
4 mg orally administered once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous LP | Experimental | Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Receives: Drug: Baricitinib (LY3009104) 2 mg |
| Dose Escalation Extension Group | Experimental | Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks Receives: Drug: Baricitinib (LY3009104) 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Assessment (PGA) of Skin Overall Response
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).
Measured: Week 16
Secondary outcomes (8)
Change in Modified CAILS Score of the Cutaneous Index Treatment
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.
Measured: Baseline, Week 16
Change in Modified CAILS Score of the Cutaneous Index Treatment
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.
Measured: Week 16, Week 28
Change in Skin Lesion Count
Change in the number of subject's skin lesions from baseline to Week 16.
Measured: Baseline, Week 16
Change in Skin Lesion Count
Change in the number of subject's skin lesions from Week 16 to Week 28.
Measured: Week 16, Week 28
Change in Pruritus Numerical Rating Scale (NRS)
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.
Measured: Baseline, Week 16
Change in Pruritus Numerical Rating Scale (NRS)
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.
Measured: Week 16, Week 28
Change in Overall Skindex-16 Assessment
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.
Measured: Baseline, Week 16
Change in Overall Skindex-16 Assessment
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.
Measured: Week 16, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start11 Jan 2022
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron R. Mangold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron R. Mangold, Mayo Clinic
- Investigators
- Aaron R Mangold, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188521
- Sponsor's protocol ID
- 21-003075
- Status last verified
- May 2024
- First submitted
- 27 Dec 2021
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhang N, Stockard AL, Leibovit-Reiben Z, Hwang AS, Kechter JA, Brumfiel CM, Patel MH, Bhullar P, Morken C, Boudreaux BW, Nassir S, Yousif M, Ogbaudu E, Xie F, Zunich S, Branch E, Dueck A, Lehman J, Pittelkow MR, Mangold AR. Repurposing the composite assessment of index lesion severity scoring system in cutaneous lichen planus. Arch Dermatol Res. 2025 Feb 14;317(1):413. doi: 10.1007/s00403-025-03996-4.
PubMed 39951132Hwang A, Kechter J, Do T, Hughes A, Zhang N, Li X, Wasikowski R, Brumfiel C, Patel M, Boudreaux B, Bhullar P, Nassir S, Yousif M, DiCaudo DJ, Fox J, Gharaee-Kermani M, Xing X, Zunich S, Branch E, Kahlenberg JM, Billi AC, Plazyo O, Tsoi LC, Pittelkow MR, Gudjonsson JE, Mangold AR. Oral Baricitinib in the Treatment of Cutaneous Lichen Planus. medRxiv [Preprint]. 2024 Jan 11:2024.01.09.24300946. doi: 10.1101/2024.01.09.24300946.
PubMed 38260663
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
- ClinicalTrials.gov ID
- NCT05188521
- Acronym / sponsor ID
- 21-003075
- Conditions
- Cutaneous Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aaron R. MangoldUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Posted 11 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutaneous LP | Experimental | Drug: Baricitinib (LY3009104) 2 mgSubjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period |
| Dose Escalation Extension Group | Experimental | Drug: Baricitinib (LY3009104) 4 mgSubject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation
- Both men and women must be at least 18 years of age at the time of screening
- Subjects must have clinical and histological features of LP
- LP requiring systemic treatment
- Subjects must have treatment naïve cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP. Failure of prior therapy: topical treatment, systemic immunosuppressant, oral metronidazole, oral sulfasalazine, oral retinoid
Key exclusion criteria (39 listed)
- On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy
- Known hypersensitivity or other adverse reaction to Baricitinib (LY3009104)
- Variants of LP deemed by the investigators to be inappropriate for Baricitinib (LY3009104) including but not limited to:
- o Drug-induced LP: Predominant non-cutaneous variants of LP, note that individuals can have disease in non-cutaneous areas; however, they must also have cutaneous disease Lichen Planopilaris or Oral Lichen planus
- Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib (LY3009104) 2 mg2 mg orally administered once daily for 16 weeks | Drug | Cutaneous LP |
| Baricitinib (LY3009104) 4 mg4 mg orally administered once daily for 12 weeks | Drug | Dose Escalation Extension Group |
Primary outcome
Physician Global Assessment (PGA) of Skin Overall Response
Time frame: 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).
8 secondary outcomes
Change in Modified CAILS Score of the Cutaneous Index Treatment
Time frame: Baseline, Week 16
Change in Modified CAILS Score of the Cutaneous Index Treatment
Time frame: Week 16, Week 28
Change in Skin Lesion Count
Time frame: Baseline, Week 16
Change in Skin Lesion Count
Time frame: Week 16, Week 28
Change in Pruritus Numerical Rating Scale (NRS)
Time frame: Baseline, Week 16
Change in Pruritus Numerical Rating Scale (NRS)
Time frame: Week 16, Week 28
Change in Overall Skindex-16 Assessment
Time frame: Baseline, Week 16
Change in Overall Skindex-16 Assessment
Time frame: Week 16, Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39951132Zhang N, Stockard AL, Leibovit-Reiben Z, Hwang AS, Kechter JA, Brumfiel CM, Patel MH, Bhullar P, Morken C, Boudreaux BW, Nassir S, Yousif M, Ogbaudu E, Xie F, Zunich S, Branch E, Dueck A, Lehman J, Pittelkow MR, Mangold AR. Repurposing the composite assessment of index lesion severity scoring system in cutaneous lichen planus. Arch Dermatol Res. 2025 Feb 14;317(1):413. doi: 10.1007/s00403-025-03996-4.
- Derived from this study: PubMed 38260663Hwang A, Kechter J, Do T, Hughes A, Zhang N, Li X, Wasikowski R, Brumfiel C, Patel M, Boudreaux B, Bhullar P, Nassir S, Yousif M, DiCaudo DJ, Fox J, Gharaee-Kermani M, Xing X, Zunich S, Branch E, Kahlenberg JM, Billi AC, Plazyo O, Tsoi LC, Pittelkow MR, Gudjonsson JE, Mangold AR. Oral Baricitinib in the Treatment of Cutaneous Lichen Planus. medRxiv [Preprint]. 2024 Jan 11:2024.01.09.24300946. doi: 10.1101/2024.01.09.24300946.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron R Mangold, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib (LY3009104) 2 mg and Baricitinib (LY3009104) 4 mg in people with Cutaneous Lichen Planus, run by Aaron R. Mangold at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Assessment (PGA) of Skin Overall Response (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.