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

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: PF-07264660; Drug: PF-07275315; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05995964

C4531002

Details and patient eligibility

About

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.

All participants in the study will receive either PF-07275315 or 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 12 weeks.

Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12.

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 will be involved in this study for up to 40 weeks (20 months). During this time, Stage 1 participants will have 16 visits at the study clinic, and Stage 2 participants will have 12 visits at the study clinic.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Must meet the following AD criteria:

1. Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;

2. Either an inadequate response to treatment with topical medications (for at least 4 consecutive weeks within 1 year 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).

   Other Inclusion Criteria:

4. BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).

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, except to single, identified, avoidable allergens (eg, peanut allergy).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 8 patient groups

Stage 1_PF-07275315

Experimental group

Description:

Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Treatment:

Drug: PF-07275315

Stage 1_PF-07264660

Experimental group

Description:

Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Treatment:

Drug: PF-07264660

Stage 1_Placebo

Experimental group

Description:

Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

Treatment:

Other: Placebo

Stage 2_PF-07275315 or PF-07264660_Dose A

Experimental group

Description:

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Treatment:

Drug: PF-07275315

Drug: PF-07264660

Stage 2_PF-07275315 or PF-07264660_Dose B

Experimental group

Description:

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Treatment:

Drug: PF-07275315

Drug: PF-07264660

Stage 2_PF-07275315 or PF-07264660_Dose C

Experimental group

Description:

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Treatment:

Drug: PF-07275315

Drug: PF-07264660

Stage 2_PF-07275315 or PF-07264660_Dose D

Experimental group

Description:

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Treatment:

Drug: PF-07275315

Drug: PF-07264660

Stage 2_Placebo

Experimental group

Description:

Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.

Treatment:

Other: Placebo