dazukibart (PF-06823859) / Pfizer - LARVOL DELTA

C0251010: A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies (clinicaltrials.gov) - P3 | N=211 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatomyositis • Immunology • Myositis

Sustained IFN Signature Suppression with Anifrolumab in a SAVI patient Refractory to JAK Inhibitor and Dazukibart Therapy. (PubMed, Arthritis Rheumatol) - "This case underscores the challenges in treating SAVI patients and highlights the utility of IFN I scores as a theragnostic biomarker. While high-dose JAKi, and dazukibart failed to achieve sustained control of IFN I signaling, treatment with anifrolumab durably suppressed IFN scores and demonstrated promising efficacy, allowing investigation of the role of IFN I signaling in the disease pathogenesis of SAVI and other interferonopathies in future clinical trials."

Journal • Inflammation • Interferonopathies • STING-Associated Vasculopathy with Onset in Infancy • CRP • IFNA1 • IFNAR1 • IFNB1 • STING

Efficacy, safety, and target engagement of dazukibart, an IFNβ specific monoclonal antibody, in adults with dermatomyositis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. (PubMed, Lancet) - P2 | "Dazukibart resulted in a pronounced reduction in disease activity and was generally well tolerated, supporting IFNβ inhibition as a highly promising therapeutic strategy in adults with dermatomyositis."

Clinical • Journal • P2 data • Dermatomyositis • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Myositis • Rare Diseases • IFNB1

A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies (clinicaltrials.gov) - P3 | N=211 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Dermatomyositis • Immunology • Myositis

Pfizer Gets CDSCO Panel Nod To Study PF-06823859 (Medical Dialogues) - "The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial for the drug PF-06823859. This came after the firm presented phase 3 clinical study protocol no. C0251010 version original, dated 08 April 2024. Dazukibart (PF-06823859) is under development for the treatment of moderate to severe dermatomyositis, cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus (SCLE), chronic cutaneous lupus erythematosus (CCLE), systemic lupus erythematosus."

Clinical protocol • Cutaneous Lupus Erythematosus • Dermatomyositis • Systemic Lupus Erythematosus

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] (clinicaltrials.gov) - P3 | N=270 | Recruiting | Sponsor: Pfizer | Trial completion date: Dec 2025 ➔ Jul 2026 | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Dermatomyositis • Immunology • Myositis

Rapid Onset of Response in Adult Dermatomyositis Patients Receiving Anti-interferon β (PF-06823859): Results of a Phase 2, Double-blind, Randomized, Placebo-Controlled Study (ACR Convergence 2023) - P2 | "Background/Purpose: Interferon (IFN) dysregulation is a key feature in the pathogenesis of Dermatomyositis (DM). PF-06823859 induced rapid improvement in 5D-itch (Wk 1), followed by CDASI-A, DLQI, and SF-36 (mental component) at Wk 4 in DM pts with SP disease. Rapid improvement in MP DM was observed at Wk 1 for PtGA, and at Wk 4 for MMT-8 and CK. The inhibition of IFNß activity by PF-06823859 is a promising treatment in DM, with a more rapid onset of efficacy potentially allowing a faster taper of steroids than current DM therapies."

Clinical • P2 data • Dermatology • Dermatomyositis • Fatigue • Immunology • Myositis • IFNB1

The anti-interferon-beta neutralizing antibody PF-06823859 significantly improves molecular and histological profiles in the skin of patients with dermatomyositis in a 12-week study (EADV 2023) - P2 | "IFNb neutralizing antibody PF-06823859 improved molecular and histological outcomes in pts with DM after 12 wks. These findings support further investigation of IFNβ as a treatment target in pts with DM."

Clinical • Dermatology • Dermatomyositis • Immunology • Myositis • IFNB1

The anti-interferon-beta neutralizing antibody PF-06823859 significantly improves molecular and histological profiles in the skin of patients with dermatomyositis in a 12-week study (EADV 2023) - P2 | "IFNb neutralizing antibody PF-06823859 improved molecular and histological outcomes in pts with DM after 12 wks. These findings support further investigation of IFNβ as a treatment target in pts with DM."

Clinical • Dermatology • Dermatomyositis • Immunology • Myositis • IFNB1

A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] (clinicaltrials.gov) - P3 | N=270 | Recruiting | Sponsor: Pfizer

New P3 trial • Dermatomyositis • Immunology • Myositis

Efficacy and safety of anti-IFNβ-specific monoclonal antibody, PF-06823859, on myositis: Phase 2 study in patients with moderate-to-severe dermatomyositis (EULAR 2023) - "There were no cases of herpes zoster or herpes simplex. Conclusion Anti-IFNβ mAb PF-06823859 was generally safe and well tolerated, improved clinical parameters (TIS, MMT-8, PhGA), patient-reported outcomes (PtGA, HAQ-DI), extra muscular activity and significantly decreased muscle enzyme levels (CK) in patients with muscle-predominant refractory moderate-to-severe DM."

Clinical • P2 data • Dermatomyositis • Gastroenterology • Gastrointestinal Disorder • Herpes Simplex • Herpes Zoster • Immune Modulation • Immunology • Myositis • Varicella Zoster • IFNB1

A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Pfizer

New P2 trial • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | N=12 ➔ 18

Enrollment change • Trial completion

The Efficacy, Safety, and Tolerability of PF-06823859, an Interferon-ß Specific Monoclonal Antibody, in Adult Patients with Skin-Predominant Dermatomyositis: Results of a Phase 2, Double-Blind, Random (AAD 2023) - No abstract available

Clinical • Late-breaking abstract • P2 data • Dermatomyositis • Immunology • Myositis

An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Aug 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

A Study In Adults With Moderate To Severe Dermatomyositis (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Dermatomyositis • Immunology • Myositis

An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study (clinicaltrials.gov) - P2 | N=9 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=30 ➔ 9 | Trial completion date: Dec 2023 ➔ Aug 2023 | Trial primary completion date: Dec 2023 ➔ Aug 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of PF-06823859 in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2022 ➔ Mar 2023 | Trial primary completion date: Aug 2022 ➔ Mar 2023

Enrollment closed • Trial completion date • Trial primary completion date

Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of PF-06823859 in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open

A Study In Adults With Moderate To Severe Dermatomyositis (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatomyositis • Immunology • Myositis

Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of PF-06823859 in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Pfizer

New P1 trial

An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study (clinicaltrialsregister.eu) - P2 | N=20 | Ongoing | Sponsor: Pfizer Inc.

New P2 trial • Dermatology • Dermatomyositis • Immunology • Inflammation • Myositis