A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Launched by PFIZER · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of two new study medications, PF-07275315 and PF-07264660, for treating moderate to severe atopic dermatitis (AD), which is a long-lasting skin condition that causes itchy, red rashes. The researchers are looking for adults aged 18 and older who have had AD for at least six months and have not found relief from current topical treatments. Participants will either receive one of the study medications or a placebo (an inactive treatment that looks like the real medicine) through multiple shots given at a clinic over 12 weeks.

If you join the study, you will have regular visits to the clinic for about 40 weeks, during which your progress will be monitored. The study aims to understand how well these medications work compared to the placebo, helping to find better treatments for people suffering from atopic dermatitis. This could be a great opportunity to contribute to important research while potentially receiving new treatment options for your condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Must meet the following AD criteria:
• • 1. Participants aged 18 years or older
• 2. Clinical diagnosis of chronic atopic dermatitis:
• • 1. for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
• • 2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weeks within 6 to 12 months of the first dose of the study intervention; OR documented reason why topical treatments are considered medically inappropriate;
• • 3. Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).
• • 4. Bio-experienced cohort-partial or non-responder to anti-inflammatory proteins, intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins.
• Other Inclusion Criteria:
• • 3. BMI of 17.5 to 40 kg/m2; and a total body weight \>45 kg (100 lbs).
• • 4. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.
• Exclusion Criteria:
• - Medical Conditions:
• • 1. Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate including but not limited to: SLE or other complement disorders; Type 1 diabetes; IBD; Multiple Sclerosis.
• • 2. History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or to the excipients of the formulated drug products. Participants with significant reactions to single, identified, avoidable allergens (eg, peanut allergy) may be eligible if avoidance of these allergens during the study is feasible.
• 3. Any of the following acute or chronic infections or infection history:
• • 1. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
• • 2. Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
• • 3. Active chronic or acute skin infection requiring treatment with systemic \[(not IV)\] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections (requiring no more than topical anti-infective treatments) within 1 week prior to Day 1.
• • 4. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
• • 4. History of or current evidence of inflammatory skin conditions (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that could interfere with evaluation of AD or response to treatment.
• • 5. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• - Prior/Concomitant Therapy:
• • 6. Current use of any prohibited concomitant medication(s).
• • 7. Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day 1.
• - Prior/Concurrent Clinical Study Experience:
• • 8. Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
• • 9. HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
• • 10. Evidence of active or latent TB, or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study.