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PF-07038124

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: Aug 26, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

PF-07038124 · 1 trial · 2 indications

Phase 2 1
NCT04664153Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque PsoriasisAtopic Dermatitis
COMPLETED104 Analytics
PHASE2COMPLETED
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants
Baseline, Week 6

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.

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
Baseline, Week 6

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.

Secondary Endpoints

Percentage of AD Participants Achieving Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6
Baseline, Week 6
Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)
Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6
Baseline, Weeks 1, 2, 4 and 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
atopic dermatitis - PF-07038124 ointmentEXPERIMENTAL -
atopic dermatitis - vehicle ointmentPLACEBO_COMPARATOR -
plaque psoriasis - PF-07038124 ointmentEXPERIMENTAL -
plaque psoriasis - vehicle ointmentEXPERIMENTAL -

Interventions

NameTypeDescription
PF-07038124 ointmentDRUGPF-07038124 ointment at 0.01% with QD dosing for 6 weeks
Vehicle ointmentDRUGVehicle ointment with QD dosing for 6 weeks
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites29

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...

Countries:United StatesAustraliaCanadaPoland
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Frequently asked questions about PF-07038124

What is PF-07038124 used for?

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.

Who makes PF-07038124?

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.

What phase is PF-07038124 in?

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.

What clinical trials is PF-07038124 in?

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.

Is PF-07038124 FDA approved?

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.

How is PF-07038124 administered?

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.