A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05995964 |
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Recruitment Status :
Recruiting
First Posted : August 16, 2023
Last Update Posted : May 17, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: PF-07275315 Drug: PF-07264660 Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 340 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | August 22, 2023 |
| Estimated Primary Completion Date : | February 26, 2026 |
| Estimated Study Completion Date : | February 26, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Stage 1_PF-07275315
Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
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Drug: PF-07275315
subcutaneous injection |
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Experimental: Stage 1_PF-07264660
Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
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Drug: PF-07264660
subcutaneous injection |
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Experimental: Stage 1_Placebo
Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
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Other: Placebo
subcutaneous injection |
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Experimental: Stage 2_PF-07275315 or PF-07264660_Dose A
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
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Drug: PF-07275315
subcutaneous injection Drug: PF-07264660 subcutaneous injection |
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Experimental: Stage 2_PF-07275315 or PF-07264660_Dose B
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
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Drug: PF-07275315
subcutaneous injection Drug: PF-07264660 subcutaneous injection |
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Experimental: Stage 2_PF-07275315 or PF-07264660_Dose C
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
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Drug: PF-07275315
subcutaneous injection Drug: PF-07264660 subcutaneous injection |
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Experimental: Stage 2_PF-07275315 or PF-07264660_Dose D
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
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Drug: PF-07275315
subcutaneous injection Drug: PF-07264660 subcutaneous injection |
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Experimental: Stage 2_Placebo
Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.
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Other: Placebo
subcutaneous injection |
- The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. [ Time Frame: Week 16 ]EASI75 (≥75% improvement from baseline) at Week 16
- 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 [ Time Frame: Screening through study completion, an average of 76 weeks. ]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
- The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16 [ Time Frame: All scheduled timepoints other than Week 16, screening through study completion, an average of 76 weeks. ]EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
- The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points [ Time Frame: Screening through study completion, an average of 76 weeks. ]Percent change from baseline in EASI total score at scheduled time points
- The number and % of participants with treatment emergent AEs [ Time Frame: Screening - Week 76 ]Incidence of treatment emergent AEs
- The number and % of participants with clinically significant changes in vital signs [ Time Frame: Screening - Week 76 ]Incidence of clinically significant changes in vital signs
- The number and % of participants with clinically significant changes in ECG [ Time Frame: Screening - Week 76 ]Incidence of clinically significant changes in ECG
- The number and % of participants with clinically significant changes in laboratory tests [ Time Frame: Screening - Week 76 ]Incidence of clinically significant changes in laboratory tests
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must meet the following AD criteria:
- Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;
- 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;
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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:
- BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).
Exclusion Criteria:
- Medical Conditions:
- 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.
- History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, except to single, identified, avoidable allergens (eg, peanut allergy).
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Any of the following acute or chronic infections or infection history:
- Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
- Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
- 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.
- Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
- 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.
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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:
- Current use of any prohibited concomitant medication(s).
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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:
- 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).
- HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05995964
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Study Director: | Pfizer CT.gov Call Center | Pfizer |
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05995964 |
| Other Study ID Numbers: |
C4531002 |
| First Posted: | August 16, 2023 Key Record Dates |
| Last Update Posted: | May 17, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Eczema |
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |