Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus

NCT05188521 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 21-003075
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).

Conditions

Cutaneous Lichen Planus

Outcome Measures

Primary Outcomes (1)

• 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).

  Week 16

Secondary Outcomes (8)

• Change in Modified CAILS Score of the Cutaneous Index Treatment

  Baseline, Week 16

• Change in Modified CAILS Score of the Cutaneous Index Treatment

  Week 16, Week 28

• Change in Skin Lesion Count

  Baseline, Week 16

• Change in Skin Lesion Count

  Week 16, Week 28

• Change in Pruritus Numerical Rating Scale (NRS)

  Baseline, Week 16

Study Arms (2)

Cutaneous LP

EXPERIMENTAL

Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period

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

Drug: Baricitinib (LY3009104) 4 mg

Interventions

Baricitinib (LY3009104) 2 mg DRUG

2 mg orally administered once daily for 16 weeks

Cutaneous LP

Baricitinib (LY3009104) 4 mg DRUG

4 mg orally administered once daily for 12 weeks

Dose Escalation Extension Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Aaron R. Mangold: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (2)

• 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.

  PMID: 39951132 DERIVED

• Hwang 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.

  PMID: 38260663 DERIVED

MeSH Terms

Conditions

Lichen Planus

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Aaron R. Mangold, Principal Investigator
• Organization: Mayo Clinic

mangold.aaron@mayo.edu

480-301-9196

Study Officials

• Aaron R Mangold, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: January 11, 2022
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-05

Locations

US (1)