Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-07038124 · 1 trial · 2 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.
| 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 | - |
| 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 |
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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| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
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PF-07038124 is an investigational small molecule being developed by Pfizer for the treatment of atopic dermatitis, also known as dermatitis atopic. It is being studied as a topical ointment for this skin condition. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
PF-07038124 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for atopic dermatitis.
PF-07038124 is in Phase 2 clinical development. A Phase 2 study has been completed that assessed the efficacy, safety, tolerability, and pharmacokinetics of PF-07038124 ointment in participants with atopic dermatitis or plaque psoriasis. The drug remains investigational and is not yet approved.
PF-07038124 has been studied in two completed clinical trials. NCT04664153 was a Phase 2 study evaluating the ointment in 104 participants with atopic dermatitis or plaque psoriasis across the United States, Australia, Canada, and Poland. NCT04135560 was a Phase 1 study in 34 healthy participants in the United States.
PF-07038124 is not FDA approved. It is an investigational drug currently in clinical development for atopic dermatitis. The completed trials include a Phase 1 study in healthy volunteers and a Phase 2 study in patients with atopic dermatitis or plaque psoriasis, but no approval has been granted.
PF-07038124 is administered as a topical ointment. Clinical trials have evaluated the drug applied to the skin in participants with atopic dermatitis or plaque psoriasis. The Phase 2 study assessed the efficacy, safety, tolerability, and pharmacokinetics of this topical formulation.