Abrocitinib for Granuloma Annulare

Overseen By William Damsky, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: William Damsky

Must not be taking: Immunosuppressives, CYP2C19/CYP2C9 inhibitors

Disqualifiers: Malignancy, HIV, Hepatitis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking systemic or topical therapies for granuloma annulare, you will need to stop them and have a washout period (time without taking these medications) of 4 weeks for systemic therapies and 2 weeks for topical therapies before starting the trial. You must remain off these therapies during the study.

How is the drug Abrocitinib different from other treatments for granuloma annulare?

Abrocitinib is unique because it is a Janus kinase (JAK) inhibitor, which works by blocking specific pathways involved in inflammation, unlike other treatments for granuloma annulare that may not target these pathways. This mechanism is different from treatments like adalimumab, which targets tumor necrosis factor (TNF)-alpha, a different inflammatory pathway. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary objective is to determine if JAK1 specific inhibition is effective in treating granuloma annulare (GA), a problematic inflammatory skin disease without an FDA approved treatment. The primary outcome will be the percentage change in the body surface area (BSA) involvement by GA after 6 months of treatment with abrocitinib 200 mg daily in 10 patients with moderate to severe GA affecting at least 5% body surface area (BSA).

Research Team

William Damsky, M.D.

Principal Investigator

Yale University

Eligibility Criteria

Adults over 18 with Granuloma Annulare covering at least 5% of their body, who've had a confirming skin biopsy. They must stop other GA treatments before starting the trial and agree to birth control if they can have children. Not for current or past smokers, pregnant/nursing women, those with certain infections or serious health conditions like heart attack history, uncontrolled ulcers, severe liver/kidney issues, blood disorders or clotting problems.

Inclusion Criteria

Written informed consent

I am able to become pregnant and agree to use birth control and have a negative pregnancy test before starting the study medication.

My skin biopsy confirms I have granuloma annulare.

Exclusion Criteria

Any medical, psychiatric, or social condition that is likely to unfavorably affect the risk-benefit of continued study participation, interfere with study compliance or confound safety or efficacy assessments

I have severe liver problems.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abrocitinib 200 mg daily for 6 months to assess its effectiveness in treating granuloma annulare

6 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abrocitinib

Trial Overview The trial is testing Abrocitinib 200 mg daily for six months on patients with moderate to severe Granuloma Annulare. The main goal is to see how much it reduces the affected skin area. Participants will undergo regular clinic visits and agree to procedures like skin biopsies and blood tests.

Participant Groups

Group I: Abrocitinib 200 mg daily Experimental Treatment 1 Intervention

6 months of treatment with abrocitinib 200 mg daily

Abrocitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Cibinqo for:

• Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Approved in United States as Cibinqo for:

• Refractory, moderate-to-severe atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable

Who Is Running the Clinical Trial?

William Damsky

Lead Sponsor

Trials

1

Recruited

10+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of widespread granuloma annulare with adalimumab: a case report. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of disseminated granuloma annulare with adalimumab. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Granuloma Annulare Secondary to Vemurafenib Therapy for Lung Adenocarcinoma. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[Two cases of granuloma annulare under anti-PD1 therapy]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Triple antibiotic combination therapy may improve but not resolve granuloma annulare. [2022]