臨床研究等提出・公開システム

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 AND PF-07264660 IN ADULT PARTICIPANTS WITH MODERATE-SEVERE ATOPIC DERMATITIS

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Not Recruiting

Nov. 21, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Must meet the following AD criteria:
1. Clinical diagnosis of chronic atopic dermatitis 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, (also known as biologics), intolerance or AEs to anti-inflammatory proteins or loss of access to anti-inflammatory proteins with >=12 weeks of treatment within 5 years.

Other Inclusion Criteria:
5. BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).
6. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Medical Conditions:
1. Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate asthma, including but not limited to: SLE or other complement disorders; Type 1 diabetes; Irritable bowel syndrome; 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:
a. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to the screening;
b. Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1;
c.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.
d. 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 would 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.

Both

Atopic Dermatitis

Stage 1: PF-07275315, PF-07264660, or Placebo subcutaneous injection over 12 weeks.
Stage 2: PF-07275315 (Dose A, Dose B, or Dose C ) or Placebo subcutaneous injection over 12 weeks.
Stage 3: Placebo subcutaneous injections for 16 weeks followed by PF-07275315 Dose A subcutaneous injections for 16 weeks, or .PF-07275315 Dose B subcutaneous injection for 32 weeks.
Stage 4: PF-07264660 (Dose A, Dose B or Dose C), or Placebo subcutaneous injection for 12 weeks.

Primary Outcome Measures :
The number of participants achieving EASI75 (>=75% improvement from baseline) at Week 16

Secondary Outcome Measures :
1. The number and % of participants achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >=2 points at all scheduled time points
2. The number and % of participants achieving EASI75 (>=75% improvement from baseline) at scheduled time points except Week 16
3. Percent change from baseline in EASI total score at scheduled time points
4. The number and % of participants with treatment emergent AEs
5. The number and % of participants with clinically significant changes in vital signs
6. The number and % of participants with clinically significant changes in ECG
7. The number and % of participants with clinically significant changes in laboratory tests

+81-6-6395-9000

April. 19, 2024

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Australia/Canada/China/Germany/Poland/United States