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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called abrocitinib, a JAK inhibitor, to determine its effectiveness in treating granuloma annulare (GA), a bothersome skin condition with no FDA-approved treatment. Researchers aim to discover if taking abrocitinib daily can reduce the affected skin area over six months. The trial seeks participants diagnosed with moderate to severe GA, especially if it covers at least 5% of their skin, and who are willing to pause other treatments during the study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential new therapies for GA.

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.

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

Research has shown that abrocitinib could be a safe and promising treatment for granuloma annulare (GA), a skin condition without FDA-approved treatments. In studies, patients who did not improve with standard treatments received abrocitinib. These studies suggest it may be well-tolerated.

Some patients who used abrocitinib for six months experienced significant improvement. Although specific details about side effects were not provided, the frequent mention of abrocitinib as a safe option suggests that any side effects might be manageable. Since abrocitinib is already used for other conditions, this provides some reassurance about its safety. However, always consult a healthcare professional if there are concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for granuloma annulare?

Unlike the standard treatments for granuloma annulare, which often include corticosteroids or immune system suppressants, abrocitinib works differently by targeting specific pathways involved in inflammation. Abrocitinib is a JAK inhibitor, which means it blocks certain enzymes that contribute to the inflammatory process. Researchers are excited about abrocitinib because it offers a new mechanism of action that could potentially provide relief for patients who don't respond well to existing therapies. This targeted approach may lead to more effective management of the condition with fewer side effects compared to traditional treatments.

What evidence suggests that abrocitinib might be an effective treatment for granuloma annulare?

Research has shown that abrocitinib, a type of medication, holds promise for treating granuloma annulare (GA), a skin condition. In earlier studies, patients experienced significant symptom improvements, with some feeling better as soon as one month after starting treatment. Those who continued using it for six months saw even greater improvements, with their skin condition markedly better. Abrocitinib is already approved for treating other skin issues like atopic dermatitis, suggesting it could also be effective for GA, especially for those who haven't found success with other treatments. ^{1 2 3 4 6}

Who Is on the Research Team?

William Damsky, M.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05650736

Janus Kinase Inhibition in Granuloma Annulare 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 ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2024.2313090

Oral abrocitinib in the treatment of granuloma annulare Abrocitinib may be a promising and safe treatment option for patients with localized GA who do not respond to traditional therapies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11616915/

Abrocitinib: A Comprehensive Review of its Efficacy and ... Abrocitinib is a novel oral small molecule which acts as a selective JAK-1 inhibitor. Currently approved for use in moderate-to-severe cases of atopic ...

4. elischolar.library.yale.edu elischolar.library.yale.edu/cgi/viewcontent.cgi?article=4240&context=ymtdl

Janus Kinase Inhibition In Granuloma Annulare - EliScholar Oral abrocitinib demonstrates efficacy after 1 month of use, and two individual patients who completed 6 months of treatment experienced substantial clinical.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38317538/

Oral abrocitinib in the treatment of granuloma annulare Results: After 6 weeks of treatment with abrocitinib, the patient exhibited notable symptom improvement with no new lesions. No adverse events ...

6. dermatologytimes.com dermatologytimes.com/view/what-s-new-in-the-medicine-chest-granuloma-annulare

What's New in the Medicine Chest: Granuloma Annulare The patient showed notable improvement, supported by photographic evidence and existing case reports. Oral JAK inhibitors, such as abrocitinib ...