Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
C4531002 Enrolling

Clinical Trials for Adults with Atopic Dermatitis (Eczema)


Treatment: Injection Age: 18 Years


Who can participate?

Adults 18 years of age or older with a moderate-to-severe Atopic Dermatitis (AD) – Eczema are needed for this clinical trial.

Inclusion Criteria:

  • Have a physician-confirmed chronic AD for at least 6 months prior to study screening.
  • Have AD lesions covering 10%* or more of body surface area (BSA)
  • Previously had inadequate response to treatment with topical medications or documented reason why topical treatments are considered medically inappropriate.

* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers)

What are the benefits?

As a participation in our research trial, you will receive an investigational treatment (active study drug) or placebo via injection at no cost. All study-related assessments will also be provided at no charge. In addition, you may also be eligible for reimbursement of study-related expenses.

How long will the study last?

  • 76 weeks and involves 11 visits to the study centre.

Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Hermenio Lima

allergist,Dermatologist

Dr. Mark Lomaga

Dermatologist

Dr. Marni Wiseman

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

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

ClinicalTrials.gov ID

NCT05995964

Sponsor

Pfizer

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: 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:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: PF-07275315
    Drug: PF-07264660
    Other: Placebo
    Drug: PF-07275315
    Drug: PF-07275315
    Drug: PF-07275315
    Drug: PF-07275315
    Other: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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;

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).

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.

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).
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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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