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Phase 2Recruiting
View on ClinicalTrials.gov

Comparing 14 approaches for atopic dermatitis

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

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

Condition: Atopic DermatitisSponsor: PfizerTarget enrollment: 340
  • Phase 2
  • 14 groups
  • Sites in Québec, Winnipeg and 5 more cities
  • Recruiting
Centre de Recherche Saint-Louis inc., QuébecWiseman Dermatology Research Inc., Winnipeg, ManitobaMedicor Research Inc, Greater Sudbury, OntarioSudbury Skin Clinique, Greater Sudbury, OntarioLima's Excellence in Allergy and Dermatology Research, Hamilton, OntarioDermEdge Research, Mississauga, OntarioToronto Research Centre, Toronto, OntarioINTERMED Groupe Sante, Chicoutimi, Quebec

Interventions

  • Medication

    PF-07275315

    subcutaneous injection

  • Medication

    PF-07264660

    subcutaneous injection

  • Other intervention

    Placebo

    subcutaneous injection

Canadian Sites (8)

8 of 8 recruiting

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba

    Recruiting
  • Medicor Research Inc

    Greater Sudbury, Ontario

    Recruiting
  • Sudbury Skin Clinique

    Greater Sudbury, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for27 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Either an inadequate response to treatment with standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → 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;
  • +BMI of 17.5 to 40 kg/m2; and a total body weight \>45 kg (100 lbs).
  • +Must meet the following AD criteria:
  • +Participants aged 18 years or older
  • +Clinical diagnosis of chronic atopic dermatitis:
  • +for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
  • +Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and baselineBaselineYour starting measurements, taken before treatment begins.Read more → visits).
  • +Bio-experienced cohortCohortA group of participants sharing a characteristic, followed together.Read more →-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 CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
  • +Willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion

  • 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, 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.
  • HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocolProtocolThe detailed plan a study must follow.Read more →-specific testing algorithm.
  • \- Medical Conditions:
  • Any of the following acute or chronic infections or infection history:
  • Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →;
  • 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.
  • 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).
  • 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).
  • 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.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 14 groups in this study.

Groups A, D, E, F and J receive PF-07275315.

Registry label: A: Stage 1_PF-07275315 · D: Stage 2_PF-07275315 _Dose A · E: Stage 2_PF-07275315 _Dose B · F: Stage 2_PF-07275315 _Dose C · J: Stage 3_PF-07275315_Dose B

Groups B, K, L and M receive PF-07264660.

Registry label: B: Stage 1_PF-07264660 · K: Stage 4_PF-07264660_Dose A · L: Stage 4_PF-07264660_Dose B · M: Stage 4_PF-07264660_Dose C

Groups C, H and N receive PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.

Registry label: C: Stage 1_Placebo · H: Stage 2_Placebo · N: Stage 4_Placebo

Group G receives PF-07275315, together with one or more of: PF-07264660.

Registry label: G: Stage 2_PF-07275315 _Dose D

Group I receives Placebo and PF-07275315.

Registry label: I: Stage 3_Placebo+PF-07275315_Dose A

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 340 people.

The study is currently expected to finish around March 2027.

The main measurement is taken over: Week 16.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

The number of participants achieving ≥75% improvement in EAS175 from baselineBaselineYour starting measurements, taken before treatment begins.Read more → at week16 — measured over Week 16.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05995964 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About PF-07275315Drug

subcutaneous injection

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PF-07264660Drug

subcutaneous injection

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PlaceboOther

subcutaneous injection

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Week 16.

The study as a whole is currently expected to finish around 2027-03-08.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 340 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 12 locations, including: Québec, Canada; Winnipeg, Manitoba, Canada; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada; Mississauga, Ontario, Canada; Toronto, Ontario, Canada, and 6 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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).

Other Sites (7)

Michigan Center for Research Company

Clarkston, Michigan, United States

MI Skin Innovations

Northville, Michigan, United States

Revival Research Institute LLC

Troy, Michigan, United States

Empire Dermatology

East Syracuse, New York, United States

Private Practice - Dr. Bobby Buka

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Sadick Research Group

New York, New York, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.