PF-07038124 / Pfizer - LARVOL DELTA

PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea (clinicaltrials.gov) - P2 | N=32 | Terminated | Sponsor: Icahn School of Medicine at Mount Sinai | Active, not recruiting ➔ Terminated; The study ended early because interim analysis showed no significant difference between the active and placebo arms.

Trial termination • Dermatitis • Dermatology • Immunology • Rosacea • Seborrheic Dermatitis

PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | N=66 ➔ 32 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Dermatitis • Dermatology • Immunology • Rosacea • Seborrheic Dermatitis

Phosphodiesterase-4 inhibitors increase pigment cells proliferation and melanization in cultured melanocytes and within a 3D skin equivalent model. (PubMed, J Invest Dermatol) - "We characterized the proliferative and melanogenic potential of two known PDE4i, crisaborole and roflumilast, and of a more recently designed compound, PF-07038124. These effects were found to be enhanced by addition of α-MSH. Our findings support the further evaluation of PDE4i with or without α-MSH agonists in vitiligo trials."

Journal • Dermatology • Immunology • Vitiligo

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: University of Colorado, Denver | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Apr 2024

Trial completion • Trial completion date • Dermatology • Immunology • Vitiligo • CXCL10 • CXCL9 • IFNG

The efficacy and safety of multiple dose levels of the PDE4 inhibitor PF-07038124 in participants 12 years and older with mild-to-moderate atopic dermatitis and mild-to-severe plaque psoriasis (SID 2024) - No abstract available

Clinical • Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. (clinicaltrials.gov) - P2 | N=264 | Completed | Sponsor: Pfizer | Phase classification: P2b ➔ P2

Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: University of Colorado, Denver | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Vitiligo • CXCL10 • CXCL9 • IFNG

Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P2a | "Topical PF-07038124 was well tolerated and demonstrated superior efficacy compared with vehicle in patients with mild to moderate AD and plaque psoriasis. ClinicalTrials.gov Identifier: NCT04664153."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo (clinicaltrials.gov) - P2a | N=64 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Jul 2023 ➔ Dec 2024 | Trial primary completion date: Jul 2023 ➔ Nov 2024

Trial completion date • Trial primary completion date • Dermatology • Immunology • Vitiligo

Next Generation PDE4 Inhibitors that Selectively Target PDE4B/D Subtypes: A Narrative Review. (PubMed, Dermatol Ther (Heidelb)) - "Phosphodiesterase 4 (PDE4) inhibitors have been approved for both oral and topical use for inflammatory skin diseases. In this review, we present a summary of an emerging class of selective PDE4B/D inhibitors under clinical development and compare the differences in selectivity of this new generation of PDE4 inhibitors with the less selective currently approved PDE4 inhibitors."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • IL13 • IL17A • IL17RA • IL23A

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. (clinicaltrials.gov) - P2b | N=265 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Icahn School of Medicine at Mount Sinai

New P2 trial • Dermatitis • Dermatology • Immunology • Rosacea • Seborrheic Dermatitis

A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. (clinicaltrials.gov) - P2b | N=246 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

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 (clinicaltrials.gov) - P2b | N=240 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Pfizer’s phosphodiesterase 4 inhibitor efficacious in atopic dermatitis, psoriasis (Healio) - P2a | N=104 | EMPORIA (NCT04664153) | Sponsor: Pfizer | "A basket study of a new topical phosphodiesterase 4 inhibitor demonstrated efficacy superior to that of placebo in mild to moderate plaque psoriasis....At the European Academy of Dermatology and Venereology Congress, Eichenfield presented results of the double-blind phase 2a study....In patients with AD, a mean difference of –39.4 in EASI score was reported vs. vehicle, whereas a mean difference in PASI score compared with vehicle was –4.9 in those with psoriasis. An improvement of at least 4 points on the Peak Pruritus Numerical Rating Scale occurred in 41.2% of the patients with AD on PF-07038124, compared with 13.8% of those on vehicle. At week 6, IGA response was significantly greater in patients with AD using PF-07038124 compared with vehicle (P = .0004). In the psoriasis population, Physician Global Assessment scores were also greater in the treatment group; however, it was not statistically significant."

P2a data • Atopic Dermatitis • Dermatology • Immunology • Psoriasis

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo (clinicaltrials.gov) - P2a | N=64 | Recruiting | Sponsor: University of Colorado, Denver | Not yet recruiting ➔ Recruiting | Initiation date: May 2022 ➔ Sep 2022

Enrollment open • Trial initiation date • Dermatology • Vitiligo

A Phase 2a basket study to assess the efficacy and safety of topical PF-07038124 in participants with atopic dermatitis and plaque psoriasis (EADV 2022) - No abstract available

Clinical • Late-breaking abstract • P2a data • Pan tumor • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

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 (clinicaltrials.gov) - P2b | N=240 | Not yet recruiting | Sponsor: Pfizer

New P2b trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo (clinicaltrials.gov) - P2a | N=64 | Not yet recruiting | Sponsor: University of Colorado, Denver

New P2a trial • Dermatology • Vitiligo

Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Pfizer; Recruiting ➔ Completed

Clinical • Trial completion

EMPORIA: Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis (clinicaltrials.gov) - P2a; N=104; Completed; Sponsor: Pfizer; Recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

EMPORIA: Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis (clinicaltrials.gov) - P2a; N=88; Recruiting; Sponsor: Pfizer; Trial completion date: Dec 2021 ➔ Sep 2021; Trial primary completion date: Dec 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Pfizer

Clinical • New P1 trial

EMPORIA: Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis (clinicaltrials.gov) - P2a; N=88; Recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis