daxdilimab (HZN-7734) / SBI Biotech, Amgen - LARVOL DELTA

Daxdilimab in Moderate-to-Severe Discoid Lupus Erythematous: Efficacy and Safety Results from a Phase 2, Randomised, Placebo-controlled Trial (EADV 2026) - P2 | No abstract available

Clinical • Late-breaking abstract • P2 data • Alopecia • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Pain

EMERGING TARGETED THERAPIES IN CUTANEOUS LUPUS ERYTHEMATOSUS: A SCOPING REVIEW OF EVIDENCE FROM 2014 TO 2026 (EADV 2026) - "Anti-BDCA2 agents, including litifilimab and VIB7734, showed reduction of interferon-driven inflammation and clinical improvement in chronic and subacute CLE...Anifrolumab, targeting IFNAR1, demonstrated rapid and sustained responses in refractory CLE and is currently under phase 3 investigation...Deucravacitinib, a selective TYK2 inhibitor, demonstrated favorable responses in discoid, subacute, tumid, and refractory CLE across multiple reports and small case series. Additional JAK inhibitors, including tofacitinib and topical ruxolitinib, also showed promising results in refractory disease. Belimumab remains the biologic therapy supported by the largest observational evidence base, with substantial CLASI improvement reported in refractory CLE cohorts. Traditional immunomodulatory agents such as thalidomide and lenalidomide continue to demonstrate efficacy in severe refractory disease, although their safety profile limits broader use...Agents directed against the type I..."

Review • Alopecia • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • IFNAR1 • SYK • TYK2

Daxdilimab Improves Disease Activity in Treatment-Refractory Discoid Lupus in Phase 2 Trial (DermatologyTimes) - "At week 24, the least-squares mean difference in change from baseline in CLASI-A versus placebo was –6.0 with low-dose daxdilimab (90% CI, –8.7 to –3.2; P = .0005) and –5.7 with high-dose daxdilimab (90% CI, –8.5 to –2.9; P = .0012). Clinically meaningful responses were also observed across the secondary endpoints. CLASI-50 response rates at week 24 were: 61.7% with low-dose daxdilimab vs 23.7% with placebo (P = .0037); 62.1% with high-dose daxdilimab vs 23.7% with placebo (P = .0044). CLA-IGA 0/1 responses were achieved by 60.3% of patients receiving low-dose daxdilimab and 51.6% receiving high-dose daxdilimab, compared with 8.9% receiving placebo (P < .0001 and P = .0007, respectively)."

P2 data • Discoid Lupus Erythematosus

Modern Therapies for Discoid Lupus Erythematosus: A Narrative Review. (PubMed, Dermatol Ther (Heidelb)) - "Ongoing advances in understanding the immune mechanisms underlying DLE are shaping a transition from broad immunosuppression toward more targeted treatment strategies. Integrating newer biologic and small-molecule therapies with conventional management may offer improved control and better long-term outcomes for patients with chronic disease."

Journal • Review • Alopecia • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • TYK2

Amgen’s bad luck in lupus may finally be coming to an end. (FierceBiotech) - "Daxdilimab significantly reduced disease severity in 72 patients with discoid lupus, an autoimmune condition marked by mostly painless sores on the skin. The phase 2 study is coded as 'terminated' on ClinicalTrials.gov because recruitment was stopped early, an Amgen spokesperson told Fierce Biotech, but the trial was in fact completed. The California company shared the result during a Feb. 3 earnings call, while also touting daxdilimab’s 'acceptable safety and tolerability profile'."

P2 data • Trial termination • Discoid Lupus Erythematosus

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM) (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Jul 2025 | Trial primary completion date: Mar 2025 ➔ Jul 2025

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

[[Translated article]]RF - New Treatments in Cutaneous Lupus Erythematosus: Current and Future Perspectives. (PubMed, Actas Dermosifiliogr) - No abstract available

Journal • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

RECAST DLE: Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus (clinicaltrials.gov) - P2 | N=72 | Terminated | Sponsor: Amgen | Active, not recruiting ➔ Terminated; Sponsor business decision, not related to safety concerns.

Trial termination • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

An Integrative Mechanistic Model of Type 1 IFN-Mediated Inflammation in Systemic Lupus Erythematosus. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Results of the global sensitivity analysis revealed baseline IFNGS, IFNα, and IFNα fraction as key factors affecting treatment benefit the most. In terms of maximum IFNGS reduction, anifrolumab showed superior potential compared to sifalimumab, daxdilimab, and litifilimab (ΔIFNGS~25%), which was further enhanced in patients with high baseline IFNGS or IFNα (ΔIFNGS~50%-60%)."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • IFNA1

'RF - New treatments in cutaneous lupus erythematosus: current and future perspectives". (PubMed, Actas Dermosifiliogr) - No abstract available

Journal • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

A focused report on IFN-1 targeted therapies for lupus erythematosus. (PubMed, Expert Opin Investig Drugs) - "Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA...This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial...Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TYK2

Efficacy and Safety Results from a Phase 2 Trial of Daxdilimab in Patients with Systemic Lupus Erythematosus (ACR Convergence 2024) - P2 | "The primary endpoint was the proportion of pts achieving a British Isles Lupus Assessment Group 2004 Index–based Combined Lupus Assessment (BICLA) response and an oral glucocorticoid dose ≤7.5 mg/day and ≤baseline dose (prednisone or equivalent) at W48. DAX did not show a significant difference vs PBO in the primary endpoint, driven by the high response rate in the PBO group (Furie P, et al. Arthritis Rheumatol. 2017; 69:376-86)."

Clinical • P2 data • Cardiomyopathy • Cardiovascular • Immunology • Inflammatory Arthritis • Lupus • Rheumatology • Systemic Lupus Erythematosus

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM) (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=96 ➔ 12 | Trial completion date: May 2027 ➔ Oct 2025 | Trial primary completion date: Oct 2026 ➔ Mar 2025

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

RECAST DLE: Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus (clinicaltrials.gov) - P2 | N=72 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

RECAST DLE: Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Amgen | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Jul 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) (clinicaltrials.gov) - P2 | N=19 | Terminated | Sponsor: Horizon Therapeutics Ireland DAC | Trial completion date: Nov 2026 ➔ Jan 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2024; Sponsor Decision

Trial completion date • Trial primary completion date • Trial termination • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

HZNP-DAX-201: Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Dermatology • Immunology

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: Horizon Therapeutics Ireland DAC

Trial completion date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

RECAST SLE OLE: Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study (clinicaltrials.gov) - P2 | N=155 | Terminated | Sponsor: Horizon Therapeutics Ireland DAC | Trial completion date: Jul 2024 ➔ Oct 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2024 ➔ Oct 2023; Sponsor Decision

Trial completion date • Trial primary completion date • Trial termination • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

HZNP-DAX-201: Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Horizon Therapeutics Ireland DAC | Phase classification: P2a ➔ P2

Phase classification • Alopecia • Immunology

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) (clinicaltrials.gov) - P2 | N=19 | Active, not recruiting | Sponsor: Horizon Therapeutics Ireland DAC | Recruiting ➔ Active, not recruiting | N=210 ➔ 19

Enrollment change • Enrollment closed • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

Emerging immunotherapeutic strategies for cutaneous lupus erythematosus: an overview of recent phase 2 and 3 clinical trials. (PubMed, Expert Opin Emerg Drugs) - "While the recent literature has few trials for CLE, drugs targeting type I interferon, its downstream signaling and plasmacytoid dendritic cells have shown promising results. Further research is required to develop long-awaited effective therapies, and this review highlights the importance of implementing trials dedicated to CLE to fill the current gap in CLE therapeutics."

Journal • P2 data • Review • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

RECAST SLE OLE: Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study (clinicaltrials.gov) - P2 | N=155 | Active, not recruiting | Sponsor: Horizon Therapeutics Ireland DAC | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Study Design and Rationale for the Efficacy and Safety Assessment of Daxdilimab, a Selective Plasmacytoid Dendritic Cell Depleter, in a Phase 2 Trial of Patients with Moderate-to-Severe Primary Discoid Lupus Erythematosus (EADV 2023) - P2 | "There is a significant unmet need for novel, fast-acting, and safe new therapies to reduce disease activity and damage and improve the quality of life for patients living with DLE. This is a proof-of-concept study that aims to evaluate a potentially new therapy in subjects with DLE. Figure."

Clinical • P2 data • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

RECAST DLE: Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Horizon Therapeutics Ireland DAC

New P2 trial • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus