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Also known as PF-07038124 ointment
PF-07038124 · 2 trials · 3 indications
EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.
| Arm | Type | Description |
|---|---|---|
| atopic dermatitis - PF-07038124 ointment | EXPERIMENTAL | - |
| atopic dermatitis - vehicle ointment | PLACEBO_COMPARATOR | - |
| plaque psoriasis - PF-07038124 ointment | EXPERIMENTAL | - |
| plaque psoriasis - vehicle ointment | EXPERIMENTAL | - |
| Part A Cohort 1 (1% Body Surface Area) | EXPERIMENTAL | Each participant in this cohort will receive both PF-07038124 0.06% and vehicle applied to the skin (1% Body Surface Area) |
| Part B Cohort 1 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 2 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 3 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 4 (10% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 5 (20% Body Surface Area) | EXPERIMENTAL | - |
| Part B Cohort 6 (10% Body Surface Area) | EXPERIMENTAL | Optional cohort of Japanese participants |
| Name | Type | Description |
|---|---|---|
| PF-07038124 ointment | DRUG | PF-07038124 ointment at 0.01% with QD dosing for 6 weeks |
| Vehicle ointment | DRUG | Vehicle ointment with QD dosing for 6 weeks |
| PF-07038124 and Vehicle | DRUG | PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA) |
| PF-07038124 or vehicle | DRUG | PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA |
Inclusion Criteria: * Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA. * Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis...
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PF-07038124 is an investigational small molecule being developed by Pfizer, Inc. as a topical ointment for atopic dermatitis. It is in Phase 2 clinical development. Pfizer is also studying the ointment in plaque psoriasis. It is not yet approved for any indication.
PF-07038124 ointment is being studied as a topical treatment for atopic dermatitis, a chronic inflammatory skin condition. It is investigational and has not been approved for marketing. Pfizer evaluated it in a Phase 2 trial that enrolled adults with atopic dermatitis or plaque psoriasis.
Pfizer, Inc. (ticker PFE) is developing PF-07038124. The company sponsored both clinical trials of the topical ointment, including the Phase 2 study in atopic dermatitis and plaque psoriasis and an earlier Phase 1 study in healthy participants.
PF-07038124 is in Phase 2 development. Two trials have been completed: a Phase 2 study in atopic dermatitis and plaque psoriasis, and a Phase 1 study in healthy participants. No active trials are currently listed, and the drug is not approved.
PF-07038124 has been tested in two completed trials. NCT04664153 was a Phase 2 study of the ointment in 104 adults with atopic dermatitis or plaque psoriasis across the United States, Australia, Canada, and Poland. NCT04135560 was a Phase 1 safety and pharmacokinetics study in 34 healthy participants in the United States.
Yes, PF-07038124 ointment is the same asset as PF-07038124. The ointment refers to the topical formulation of the small molecule that Pfizer is developing for atopic dermatitis. Both names describe the same investigational drug candidate.