dazukibart (PF-06823859) / Pfizer - LARVOL DELTA

Novel therapies for refractory idiopathic inflammatory myopathy-associated interstitial lung disease. (PubMed, Curr Opin Rheumatol) - "Across these agents, evidence is confined to case reports, small series, and observational cohorts, with few randomized trials reporting IIM-ILD-specific outcomes. Prospective studies are needed to define patient selection, treatment sequencing and combinations, durability, and safety of novel therapies in IIM-ILD."

Journal • Dermatomyositis • Immunology • Interstitial Lung Disease • Melanoma • Myositis • Oncology • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Solid Tumor • IFIH1

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=318 | Recruiting | Sponsor: Pfizer | Trial completion date: Jul 2027 ➔ Jul 2030 | Trial primary completion date: Jul 2027 ➔ Jul 2030

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

Precision Over Prednisone: Mechanism-Based Therapy for Dermatomyositis in the Modern Era (ACR Convergence 2026) - "Numerous advances in therapeutic agents targeting key pathways in dermatomyositis have been made, with large ongoing or completed clinical trials of several agents, including brepocitinib (TYK2/JAK1 inhibitor), dazukibart (interferon [IFN] β blockade), anifrolumab (type I IFN receptor blockade), and efgartigimod (neonatal Fc receptor [FcRn] inhibitor), showing significant promise to transform the therapeutic landscape in myositis in the near term. Dissemination of these recent data would benefit the rheumatology community at large. Learning Objectives: Using a case-based approach, Explain the rationale for use of immunoglobulin therapy in myositis, with special emphasis in conditions where clinical trial data is available to guide its implementation Identify practical scenarios where IVIG therapy is indicated and potential pitfalls commonly encountered with IVIG therapy, to aid clinicians in optimizing treatment of patients Explain critical pathways in the pathogenesis..."

Dermatomyositis • Immunology • Myositis • TYK2

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 | Trial completion date: Nov 2027 ➔ Jul 2031 | Trial primary completion date: Nov 2027 ➔ Jul 2031

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

Long-term Safety and Efficacy of Dazukibart in Dermatomyositis: Combined Phase 2 Results from Double-blind and Open-Label Extension Studies. (PubMed, J Rheumatol) - "The safety and efficacy profiles of dazukibart observed at 24 weeks were sustained through 92 weeks."

Journal • P2 data • Dermatomyositis • Immunology • Myositis

Rapid Onset of Response in Adults with Dermatomyositis Receiving Dazukibart: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study. (PubMed, Clin Cosmet Investig Dermatol) - P2 | "The small sample size of the MP cohort warrants a well-powered Phase 3 study to confirm these Phase 2 proof-of-concept results. NCT03181893."

Journal • P2 data • Dermatology • Dermatomyositis • Immunology • Myositis • IFNB1

Early exposure-response modeling of an interferon-beta monoclonal antibody (dazukibart) in adults with dermatomyositis. (PubMed, J Pharmacokinet Pharmacodyn) - No abstract available

Journal • Dermatomyositis • Immunology • Myositis

Compassionate use efficacy of the interferon-beta inhibitor dazukibart in dermatomyositis. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Dermatomyositis • Immunology • Myositis

A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; Pfizer has made an internal business decision to not continue this study. This decision was not due to safety concerns or clinical effect reasons or requests from any regulatory authorities.

Trial termination • 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=318 | Recruiting | Sponsor: Pfizer | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2026 ➔ Jul 2027

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

Dazukibart for the treatment of severe TIF1γ-positive juvenile dermatomyositis. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Dermatomyositis • Immunology • Myositis

A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (clinicaltrials.gov) - P2 | N=6 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=48 ➔ 6 | Trial completion date: Nov 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Updates in juvenile dermatomyositis: pathogenesis and therapy. (PubMed, Curr Opin Rheumatol) - "Growing evidence show genetic markers, MSA, IFN, vasculopathy, varied immune cells, and mitochondrial dysfunction having important roles in JDM pathogenesis. Some refractory patients show benefit with newer IFN pathway-targeted therapies and cellular CAR-T-cell therapy. Further collaborative research on disease pathogenesis, treatment targets, and innovate clinical trial design is needed to increase access to more efficacious treatments in JDM."

IO biomarker • Journal • Dermatomyositis • Immunology • Metabolic Disorders • Myositis • IFNAR1

Dazukibart for dermatomyositis: expanding the therapeutic arsenal. (PubMed, Ann Transl Med) - No abstract available

Journal • Dermatomyositis • Immunology • Myositis

Pharmacokinetics, Safety, and Tolerability of Single-Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double-Blind, Phase 1 Studies. (PubMed, Clin Pharmacol Drug Dev) - P1 | "No participants in Study 1 were antidrug antibody positive; 20.0% in Study 2 were positive for treatment-induced antidrug antibodies and neutralizing antibodies. PK parameters and immunogenicity rates were consistent with the US study, and no new safety signals were identified."

Clinical • Journal • P1 data • PK/PD data • IFNB1

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