A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Study Details
Study Description
Brief Summary
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:
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are 18 years of age or more.
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Were confirmed to have AD at least 6 months ago.
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Are not having an effective treatment result from medicines that are applied on skin for AD.
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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 80 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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: PF-07275315
subcutaneous injection
|
| 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. |
Drug: PF-07264660
subcutaneous injection
|
| 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. |
Other: Placebo
subcutaneous injection
|
| 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. |
Drug: PF-07275315
subcutaneous injection
Drug: PF-07264660
subcutaneous injection
|
| 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. |
Drug: PF-07275315
subcutaneous injection
Drug: PF-07264660
subcutaneous injection
|
| 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. |
Drug: PF-07275315
subcutaneous injection
Drug: PF-07264660
subcutaneous injection
|
| 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. |
Drug: PF-07275315
subcutaneous injection
Drug: PF-07264660
subcutaneous injection
|
| Experimental: Stage 2_Placebo Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12. |
Other: Placebo
subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. [Week 16]
EASI75 (≥75% improvement from baseline) at Week 16
Secondary Outcome Measures
- The number and % of participants achieving IGA 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 [Screening through study completion, an average of 76 weeks.]
IGA 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 [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 [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 [Screening - Week 76]
Incidence of treatment emergent AEs
- The number and % of participants with clinically significant changes in vital signs [Screening - Week 76]
Incidence of clinically significant changes in vital signs
- The number and % of participants with clinically significant changes in ECG [Screening - Week 76]
Incidence of clinically significant changes in ECG
- The number and % of participants with clinically significant changes in laboratory tests [Screening - Week 76]
Incidence of clinically significant changes in laboratory tests
Eligibility Criteria
Criteria
Inclusion Criteria:
Must meet the following AD criteria:
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Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;
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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 (captured as part of EASI) ≥10%, IGA ≥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:
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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; Irritable bowel syndrome; Multiple Sclerosis.
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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:
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Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to the screening;
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Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1;
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Active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections within 1 week prior to Day
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Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
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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.
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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:
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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:
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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).
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HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Marvel Clinical Research | Huntington Beach | California | United States | 92647 |
| 2 | Renaissance Research and Medical Group | Cape Coral | Florida | United States | 33991 |
| 3 | Floridian Research Institute | Miami | Florida | United States | 33179 |
| 4 | Virginia Dermatology and Skin Cancer Center | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4531002