A Study To Learn About The Safety, Efficacy and Tolerability of PF-07038124 Ointment In Participants With Mild-To-Moderate Atopic Dermatitis Or Mild-To-Severe Plaque Psoriasis

Study Purpose

The purpose of this clinical trial is to learn about how the safety, how well the study medicine works, extent to which side affects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for AD population:

  • - Diagnosis of Atopic Dermatitis (AD) for at least 3 months.
  • - Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate) - AD covering 5% and up to 40% of Body Surface Area (BSA) - A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2.
Inclusion Criteria for Plaque Psoriasis.
  • - Diagnosis of Plaque Psoriasis (PsO) for at least 6 months.
  • - Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe) - PsO covering 2% to 20% (inclusive) of BSA.

Exclusion Criteria:

  • - Presence of skin comorbidities that would interfere with study assessment or response to treatment.
  • - Psychiatric condition including recent or active suicidal ideation or behavior.
  • - Current or recent history of severe, progressive, or uncontrolled disease.
  • - A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
  • - Recent, significant trauma or major surgery.
  • - History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
  • - History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
  • - Use of any prohibited concomitant medication(s) - Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • - Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old) - Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
  • - Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec.
- A recent history of alcohol or substance abuse

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05375955
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Atopic Dermatitis PF-07038124 0.01% ointment

Atopic Dermatitis

Placebo Comparator: Atopic Dermatitis Vehicle ointment

Atopic Dermatitis

Experimental: Atopic Dermatitis PF-07038124 0.03% ointment

Atopic Dermatitis

Experimental: Plaque Psoriasis PF-07038124 0.01% ointment

Plaque Psoriasis

Experimental: Plaque Psoriasis PF-07038124 0.03% ointment

Plaque Psoriasis

Experimental: Plaque Psoriasis PF-07038124 0.06% ointment

Plaque Psoriasis

Placebo Comparator: Plaque Psoriasis Vehicle ointment

Plaque Psoriasis

Interventions

Drug: - PF-07038124 ointment 0.01%

Atopic Dermatitis and Plaque Psoriasis

Drug: - Vehicle ointment

Atopic Dermatitis and Plaque Psoriasis

Drug: - PF-07038124 ointment 0.03%

Atopic Dermatitis and Plaque Psoriasis

Drug: - PF-07038124 ointment 0.06%

PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Pfizer CT.gov Call Center

[email protected]

1-800-718-1021

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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