Baricitinib for 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Baricitinib, a Janus kinase inhibitor, for individuals with Cutaneous Lichen Planus, a skin condition causing itchy, flat-topped bumps. The study aims to determine if Baricitinib can reduce symptoms and improve skin health. Participants whose Cutaneous Lichen Planus has resisted other treatments or requires systemic treatment might be suitable candidates. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that Baricitinib is likely to be safe for humans?

Research has shown that baricitinib is generally safe for people. In studies on its use for skin conditions like cutaneous lichen planus, baricitinib was well-tolerated. Patients responded positively to treatment, with side effects that were usually easy to manage. Some studies even reported quick symptom relief, indicating that the body handles the drug well. While side effects can occur, they are usually mild, such as headaches or an upset stomach. Overall, baricitinib is already approved for other conditions, which supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for cutaneous lichen planus, like corticosteroids and immunosuppressants, aim to reduce inflammation and suppress the immune system. But Baricitinib works differently, targeting specific proteins involved in the inflammatory process known as Janus kinases (JAKs). This targeted approach could offer a more precise way to manage the condition with potentially fewer side effects. Researchers are excited because Baricitinib may provide relief for patients who don't respond well to existing therapies, offering a new hope for controlling this chronic skin condition.

What evidence suggests that Baricitinib might be an effective treatment for Cutaneous Lichen Planus?

Research has shown that Baricitinib may help treat Cutaneous Lichen Planus (LP). In one study, 83.3% of patients improved after 16 weeks of treatment, indicating that most participants experienced better LP symptoms. The study used the Physician Global Assessment (PGA) to assess changes in the condition. These results suggest that Baricitinib could be a promising option for managing Cutaneous LP. Participants in this trial will receive Baricitinib, starting at a 2 mg dose, with the possibility of increasing to 4 mg if they respond but have not achieved a PGA score of 0. ^{1 3 4 6 7}

Who Is on the Research Team?

Aaron R Mangold, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Baricitinib (LY3009104)

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05188521

Baricitinib (LY3009104) in the Treatment of Cutaneous ... This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38260663/

Oral Baricitinib in the Treatment of Cutaneous Lichen Planus Results: An early and sustained clinical response was seen with 83.3% of patients responsive at week 16. Our molecular data identified a unique, ...

3. jaad.org jaad.org/article/S0190-9622(24)01139-3/fulltext

54033 Baricitinib in Cutaneous Lichen Planus- Phase 2 ... Twelve patients with biopsy-proven cutaneous LP were trialed on baricitinib 2 mg daily for 16-weeks. The primary endpoint was physician global assessment (PGA) ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20525704

A Study to Evaluate Baricitinib (LY3009104) to Treat ... The purpose of this study is to evaluate the safety and efficacy of Baricitinib (LY3009104) in cutaneous LP as assessed by the change in Physician Global ...

5. jci.org jci.org/articles/view/179436

Rapid response of lichen planus to baricitinib associated ... An early and sustained clinical response was seen, with 83.3% of patients responsive at week 16. Our molecular data identified a unique, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11735091/

Rapid response of lichen planus to baricitinib associated with ... This study demonstrates the safety and efficacy of baricitinib and identifies a novel T-cell subset as a major source of IFN-γ in cutaneous ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/21/NCT05188521/Prot_SAP_000.pdf

Baricitinib (LY3009104) in the Treatment of Cutaneous ... as the construction and implementation of a site data and safety-monitoring plan (see section 10 “Study. Monitoring, Auditing, and Inspecting ...