Abrocitinib for Sarcoidosis
Trial Summary
What is the purpose of this trial?
This trial is testing a new pill called abrocitinib for patients with moderate to severe skin sarcoidosis. The pill aims to reduce inflammation by targeting a specific protein in the immune system. Researchers hope this will improve skin lesions better than current treatments.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify that you must stop all current medications. However, you must be on a stable dose of any systemic therapies for sarcoidosis for at least 3 months, with no plans to change them in the next 6 months. You can continue taking low-dose prednisone (up to 20 mg daily) or methotrexate (up to 15 mg weekly). There is a 2-week washout period for topical medications.
Will I have to stop taking my current medications?
You may need to stop some medications, but you can continue taking low-dose prednisone (up to 20 mg daily) or methotrexate (up to 15 mg weekly). There is a 2-week washout period for topical medications, but most oral medications cannot be stopped.
What data supports the idea that Abrocitinib for Sarcoidosis is an effective drug?
The available research does not provide specific data on Abrocitinib for Sarcoidosis. However, studies on a similar drug, Tofacitinib, which also targets the same pathway, show promising results. In one study, 10 patients with skin sarcoidosis treated with Tofacitinib showed improvement, with 6 experiencing complete recovery. Another study found that Tofacitinib helped 60% of patients with lung sarcoidosis reduce their steroid use without worsening symptoms. These findings suggest that drugs targeting the same pathway as Abrocitinib could be effective for Sarcoidosis, but more research is needed specifically on Abrocitinib.12345
What data supports the effectiveness of the drug Abrocitinib for treating sarcoidosis?
What safety data is available for Abrocitinib in treating sarcoidosis?
The provided research does not contain specific safety data for Abrocitinib (also known as Cibinqo or PF-04965842) in the treatment of sarcoidosis. The studies mentioned focus on other treatments like infliximab, TNF antagonists, and tofacitinib for sarcoidosis, but do not provide safety information on Abrocitinib.12367
Is the drug Abrocitinib a promising treatment for sarcoidosis?
How does the drug Abrocitinib differ from other treatments for sarcoidosis?
Abrocitinib is a Janus kinase (JAK) inhibitor, which is a novel approach for treating sarcoidosis by targeting specific immune pathways involved in the disease. Unlike traditional treatments like glucocorticoids, which have broad effects, JAK inhibitors like Abrocitinib specifically suppress certain immune responses, potentially reducing side effects and improving outcomes.12348
Research Team
William Damsky, M.D.
Principal Investigator
Yale University
Eligibility Criteria
Adults with moderate to severe cutaneous sarcoidosis, confirmed by skin biopsy, can join this trial. They must have been on stable medication doses for 3 months if using other treatments and agree to not change these during the study. Women who can get pregnant need a negative pregnancy test and must use birth control. People with certain infections, liver or kidney issues, clotting disorders, cancer (except certain skin cancers), or taking strong drug inhibitors are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abrocitinib 200 mg daily for 6 months to assess its effectiveness in treating moderate to severe cutaneous sarcoidosis
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of molecular signatures and adverse events
Treatment Details
Interventions
- Abrocitinib
Abrocitinib is already approved in European Union, United States for the following indications:
- Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Pfizer
Industry Sponsor
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