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

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-07275315 — DRUG
  subcutaneous injection
• PF-07264660 — DRUG
  subcutaneous injection
• Placebo — OTHER
  subcutaneous injection

Study Details

The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: * are 18 years of age or more. * Were confirmed to have AD at least 6 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. In Stage 1 of the study, participants will receive either PF-07275315 or PF-07264660 or placebo. Stage 1 is complete. In Stage 2 of the study participants will receive either PF-07275315 or placebo. In Stage 3 of the study participants who have received anti-inflammatory proteins, will receive either PF-07275315 or placebo. In Stage 4 of the study participants will receive either PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied. PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of each Stage. The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective. Participants in Stages 1, 2 and 4 will be involved in this study for up to 40 weeks (10 months). Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months).

Key Dates

Start date

Aug 22, 2023

Status verified

Apr 2026

Primary completion

Oct 19, 2026

Completion

Mar 8, 2027

Study Design

Enrollment

340 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stage 1_PF-07275315
  Stage 1 PF-07275315 Injections over 12 weeks
• Experimental: Stage 1_PF-07264660
  Stage 1 PF-07264660 Injections over 12 weeks
• Experimental: Stage 1_Placebo
  Stage 1 Placebo Injections over 12 weeks
• Experimental: Stage 2_PF-07275315 _Dose A
  Stage 2 PF-07275315 Injections over 12 weeks.
• Experimental: Stage 2_PF-07275315 _Dose B
  Stage 2 PF-07275315 Injections over 12 weeks.
• Experimental: Stage 2_PF-07275315 _Dose C
  Stage 2 PF-07275315 Injections over 12 weeks.
• Experimental: Stage 2_PF-07275315 _Dose D
  Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks.
• Experimental: Stage 2_Placebo
  Stage 2 Placebo Injections over 12 weeks.
• Experimental: Stage 3_Placebo+PF-07275315_Dose A
  Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks.
• Experimental: Stage 3_PF-07275315_Dose B
  Stage 3 PF-07275315 Injections for 32 weeks.
• Experimental: Stage 4_PF-07264660_Dose A
  Stage 4 PF-07264660 Injections for 12 weeks
• Experimental: Stage 4_PF-07264660_Dose B
  Stage 4 PF-07264660 Injections for 12 weeks
• Experimental: Stage 4_PF-07264660_Dose C
  Stage 4 PF-07264660 Injections for 12 weeks
• Experimental: Stage 4_Placebo
  Stage 2 Placebo Injections for 12 weeks

Primary Outcome Measure

The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. [ Time Frame: Week 16 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (52)

Find similar trials in Birmingham, AL

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