Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus

Overseen By Brett Renner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aaron R. Mangold

Must not be taking: Baricitinib

Disqualifiers: Pregnancy, Active infections, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing Baricitinib, a medication that reduces inflammation, on patients with Cutaneous Lichen Planus, a skin condition with itchy bumps. The drug helps by calming the immune system to lessen skin irritation.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should not be on excluded therapies or should be on a stable dose of a therapy. It's best to discuss your current medications with the study team to see if any adjustments are needed.

Is baricitinib generally safe for humans?

Baricitinib has been studied in healthy volunteers and patients with rheumatoid arthritis, showing it is generally safe and well tolerated. No serious treatment-related adverse events were reported, although a reversible decline in certain blood cells was observed. ^{1 2 3 4 5}

Research Team

Aaron R Mangold, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Subjects must have clinical and histological features of LP

LP requiring systemic treatment

Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator

Exclusion Criteria

Women of childbearing potential not using basic methods of contraception

You have had a bad reaction or are allergic to the study drug Baricitinib.

Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 mg of Baricitinib for 16 weeks

16 weeks

Dose Escalation Extension

Participants who respond but do not achieve PGA 0 receive 4 mg of Baricitinib for an additional 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Baricitinib (LY3009104)

Participant Groups

Group I: Dose Escalation Extension Group Experimental Treatment 1 Intervention

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

Group II: Cutaneous LP Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Aaron R. Mangold

Lead Sponsor

Trials

3

Recruited

40+

Findings from Research

Baricitinib, a selective JAK1 and JAK2 inhibitor, was found to be safe and well tolerated in healthy volunteers, with no serious treatment-related adverse events reported during the studies.

The drug demonstrated predictable pharmacokinetics, achieving peak plasma concentration within 1.5 hours and showing a dose-linear response, which suggests it could be effective for treating rheumatoid arthritis and other inflammatory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers. Shi, JG., Chen, X., Lee, F., et al.[2021]

Baricitinib demonstrated a consistent safety profile over 128 weeks in patients with rheumatoid arthritis, with treatment-emergent adverse events occurring in 63% of patients on 4 mg and 67% on 8 mg, and no unexpected late safety signals identified.

Clinical improvements in disease symptoms were maintained beyond the initial 24-week blinded period, with similar or increased rates of disease improvement observed at weeks 76 and 128, indicating the long-term efficacy of baricitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. Keystone, EC., Genovese, MC., Schlichting, DE., et al.[2021]

In a study involving 4731 rheumatoid arthritis patients treated with baricitinib over 24 weeks, 26.57% achieved remission, indicating its effectiveness in real-world clinical practice.

The treatment was associated with a 26.87% incidence of adverse events, including serious infections and other complications, highlighting the need for ongoing safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of baricitinib for rheumatoid arthritis in Japanese clinical practice: 24-week results of all-case post-marketing surveillance. Takagi, M., Atsumi, T., Matsuno, H., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Changes in selected haematological parameters associated with JAK1/JAK2 inhibition observed in patients with rheumatoid arthritis treated with baricitinib. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of baricitinib for rheumatoid arthritis in Japanese clinical practice: 24-week results of all-case post-marketing surveillance. [2023]