AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma - LARVOL DELTA

Adebrelimab combined with vunakizumab for first-line maintenance treatment of extensive-stage small cell lung cancer: A prospective, single-center, single-arm clinical study (ChiCTR) - P4 | N=43 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Nanjing Medical University; The First Affiliated Hospital of Nanjing Medical University

New P4 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Vunakizumab in Patients with Active Ankylosing Spondylitis by Cigarette Smoking Status: A Post Hoc Analysis of a Randomized, Double-blind, Phase 2/3 Study (ACR Convergence 2025) - P2/3 | "Vunakizumab 120 mg showed significant efficacy and favorable safety in patients with active AS, regardless of cigarette smoking status."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy of Vunakizumab in Reducing Pain in Ankylosing Spondylitis: A Post-Hoc Analysis of a Phase 2/3 Clinical Trial (ACR Convergence 2025) - "Vunakizumab provided statistically significant and clinically meaningful reductions in pain outcomes in patients with active AS. Importantly, patients who switched from placebo to vunakizumab at week 16 experienced rapid pain improvement, supporting vunakizumab as an effective treatment strategy for managing pain in AS."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology • Seronegative Spondyloarthropathies • IL17A

Efficacy And Safety of Vunakizumab in Patients with Active Ankylosing Spondylitis Stratified by Disease Course: A Post-hoc Analysis of a Randomized, Double-Blind, Phase 2/3 Trial (ACR Convergence 2025) - P2/3 | "Vunakizumab 120 mg showed improved efficacy with a manageable safety profile in patients with active AS, irrespective of DC."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Vunakizumab for Treatment of Acrodermatitis Continua of Hallopeau: A Case Report and Literature Review. (PubMed, Psoriasis (Auckl)) - "Emerging evidence indicates that elevated IL-17 levels modulate keratinocyte proliferation and immune cell infiltration, contributing to ACH pathogenesis and representing a promising therapeutic target. Herein, we presented a case of ACH successfully treated with vunakizumab, China's first self-developed anti-IL-17A monoclonal antibody, and reviewed publications reporting IL-17 targeted therapies for ACH, highlighting the potential benefit of IL-17 targeted therapy in ACH management."

Journal • Dermatitis • Dermatology • Immunology • Psoriasis • Pustular Psoriasis • IL17A

Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis across different regions of China: a post-hoc exploratory analysis of a phase III, randomized controlled trial. (PubMed, J Dermatolog Treat) - P3 | "The incidence of adverse events was 80.5%, 90.1%, and 90.1% in the North, Central, and South China groups, respectively. The efficacy and safety of vunakizumab are not affected by different regions of China in patients with moderate-to-severe plaque psoriasis."

Clinical • Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis • IL17A

Efficacy and Safety of Vunakizumab in Psoriasis Patients with Prior IL-17 Inhibitor Failure: A Retrospective Study from China (EADV 2025) - "Vunakizumab has demonstrated favorable effectiveness and safety in patients with secukinumab or ixekizumab therapy failures."

Retrospective data • Dermatology • Immunology • Psoriasis • IL17A • IL23A • TNFA

Early response to vunakizumab and its baseline predictors in patients with moderate-to-severe plaque psoriasis: a post hoc analysis of a phase-III trial. (PubMed, J Dermatolog Treat) - P3 | "The nomogram demonstrated good calibration performance (mean absolute error: 0.021) with a limited discriminative ability (C-index: 0.580). Early response rate to vunakizumab was 54.0% in patients with moderate-to-severe plaque psoriasis, where female gender and naïve status to local therapy predicted early response."

Clinical • Journal • P3 data • Retrospective data • Dermatology • Immunology • Psoriasis

Efficacy and Safety of Vunakizumab in Scalp Psoriasis :A Case Report of Three Patients (EADV 2025) - P3 | "PSSI score of patient 3 who once treated with Secukinumab also achieved significant improvement .No adverse events were reported during the observation period. Vunakizumab, an IL-17A inhibitor, demonstrated rapid and profound efficacy in three patients with severe scalp psoriasis, nearly achieving complete lesion clearance by 8 weeks. These findings align with phase III trial data, supporting its role as a potent therapeutic option for recalcitrant scalp involvement. Larger studies are warranted to confirm long-term safety and durability."

Case report • Clinical • Dermatology • Immunology • Psoriasis • IL17A

Efficacy and safety of switching biological agents to Vunakizumab in patients with plaque psoriasis: a multicenter prospective observational study (EADV 2025) - "Baseline Characteristics and Clinical Outcomes PARAMETER BASELINE WEEK 8 CHANGE MEDIAN PASI (RANGE) 9.4 (3.3–25.2) 1.6 (0.6–3.2) -83% IGA ≥3, N (%) 13 (86.7%) 0 (0%) — IGA 0/1, N (%) 0 (0%) 15 (100%) — MEDIAN BSA % (RANGE) 20 (5-62) 10 (2-17) -50% MEDIAN DLQI (RANGE) 15 (9–25) 5 (0–9) -66.7% DEMOGRAPHICS MEAN AGE (YEARS) 35.5 ± 8.2 — — MALE, N (%) 13 (86.7%) — — PRIOR THERAPIES IL-17A INHIBITORS, N (%) 10 (66.7%) — — TNF-Α INHIBITORS, N (%) 3 (20%) — — OTHER BIOLOGICS*, N (%) 2 (13.3%) — — *Including guselkumab. Vunakizumab demonstrated rapid and profound efficacy in patients resistant to multiple biologics, achieving 100% IGA 0/1 response with no significant safety concerns. Its high binding affinity for IL-17A may explain its salvage potential. Larger, long-term studies are needed to validate these findings."

Clinical • Observational data • Dermatology • Immunology • Infectious Disease • Psoriasis • IL17A

Refractory Palmoplantar Pustulosis Achieving Remission with Anti-IL-17A Agent Vunakizumab (EADV 2025) - "We report a case of refractory PPP that exhibited significant clinical improvement following 6 weeks of vunakizumab treatment. The patient remains on this therapeutic regimen, with ongoing follow-up to evaluate the treatment's long-term efficacy and safety. The treatment rationale for this case was informed by a randomized controlled trial which demonstrated the efficacy of an IL-17RA inhibitor, brodalumab, in PPP management."

Clinical • Dermatology • Immunology • Inflammation • Pruritus • Psoriasis • IL13 • IL17A • IL17RA • IL4

Successful treatment of a 15-year-old male with severe plaque psoriasis using Vunakizumab (anti-IL-17) - a case report (EADV 2025) - "We present the case of a 15-year-old adolescent patient with severe plaque psoriasis who was successfully treated with Vunakizumab. Clinical studies have demonstrated quick and meaningful responses to Vunakizumab in moderate-to-severe plaque psoriasis within 12 weeks. Likewise, our patient exhibited considerable improvement of both skin lesions and quality of life after just 4 weeks of treatment, with sustained response at 28 weeks."

Case report • Clinical • Dermatology • Immunology • Psoriasis • IL17A

Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. (PubMed, Expert Opin Drug Metab Toxicol) - P1 | "Both injection devices were well-tolerated in terms of safety. Participants preferred a single 2 mL subcutaneous injection over two 1 mL subcutaneous injections.Clinical Trial Registration www.clinicaltrials.gov, identifier: NCT06182384."

Journal • PK/PD data • Dermatitis • Dermatology • Immunology • Pain • Psoriasis • IL17A

Comparison of patient-reported outcomes in patients achieving complete versus near-complete skin clearance following Vunakizumab treatment: a post-hoc analysis of a phase III trial. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - P3 | "Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance."

Journal • P3 data • Retrospective data • Dermatology • Immunology • Pruritus • Psoriasis

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Chinese SLE Treatment And Research Group | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2027 ➔ Dec 2027 | Trial primary completion date: Oct 2025 ➔ Nov 2026

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Effects of Vunakizumab Treatment on Detailed Dimensions of Patient-Reported Outcomes in Moderate-to-Severe Plaque Psoriasis Patients: A Post-Hoc Analysis of a Randomized Controlled Trial (NCT04839016). (PubMed, Clin Ther) - P3 | "Vunakizumab sustainedly improves overall PROs in Chinese moderate-to-severe plaque psoriasis patients, especially in the dimensions of mental, neurological, and behavioral feelings."

Journal • Retrospective data • CNS Disorders • Depression • Dermatology • Immunology • Mood Disorders • Pain • Pruritus • Psoriasis • Psychiatry

Real-World Study on the Clinical Efficacy and Safety of Vunakizumab in the Treatment of Moderate-to-Severe Plaque Psoriasis (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Dematology Hospital of Southern Medical University; Dematology Hospital of Southern Medical University

New trial • Real-world evidence • Dermatology • Immunology • Psoriasis

The efficacy of secukinumab in treating active ankylosing spondylitis and the situation of different dosage reduction regimens after achieving treatment targets: A multicenter prospective cohort study (ChiCTR) - P4 | N=238 | Not yet recruiting | Sponsor: First Affiliated Hospital of Kunming Medical University; First Affiliated Hospital of Kunming Medical University

New P4 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study on the First-line Treatment of Small Cell Lung Cancer With Adebrelimab and Vunakizumab and Chemotherapy (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Trial completion date: Feb 2028 ➔ Dec 2028 | Trial primary completion date: Apr 2027 ➔ Feb 2028

Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Immunology • Seronegative Spondyloarthropathies • Spondylarthritis

EFFICACY AND SAFETY OF VUNAKIZUMAB ON ENTHESITIS IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: A POST-HOC ANALYSIS FROM A RANDOMIZED, DOUBLE-BLIND, PHASE 2/3 STUDY (EULAR 2025) - "This post-hoc analysis showed that vunakizumab 120 mg significantly improved enthesitis, as measured by the MASES score, in comparison to placebo at week 16 in patients with active AS. Furthermore, subsequent switching from placebo to vunakizumab also resulted in considerable improvement in enthesitis in this population."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • IL17A

EFFECT OF VUNAKIZUMAB ON PATIENT-REPORTED OUTCOMES IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PHASE 2/3 STUDY (EULAR 2025) - P2/3 | "Treatment with vunakizumab provides significant and sustained improvements in patient-reported disease activity, functional impairment, health-related quality of life, and pain in patients with active ankylosing spondylitis."

Clinical • P2/3 data • Patient reported outcomes • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies • IL17A

EFFICACY AND SAFETY OF VUNAKIZUMAB IN ANKYLOSING SPONDYLITIS: A SUBGROUP ANALYSIS BY GENDER (EULAR 2025) - P2/3 | "Vunakizumab 120 mg demonstrated statistically significant and clinically meaningful improvements in AS symptoms across both male and female patient populations, with a rapid onset of response observed by week 2. The safety profile was manageable and tolerable. These findings highlight the potential of vunakizumab as an effective treatment option for AS patients, regardless of gender."

Clinical • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Efficacy and safety of vunakizumab in active ankylosing spondylitis with and without prior TNF-a inhibitor exposure: a post-hoc analysis of a randomized, double-blind, phase 2/3 study (EULAR 2025) - P2/3 | "Vunakizumab showed efficacy and acceptable safety in patients with active AS, regardless of prior TNFi exposure. These findings warrant validation in future studies."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A

Vunakizumab Therapeutic Response in Ankylosing Spondylitis: Insights from BMI-Based Subgroup Analysis (EULAR 2025) - P2/3 | "Vunakizumab 120 mg significantly improved AS symptoms across BMI categories, with consistent efficacy and rapid response observed in both subgroups. These results highlight its potential as a valuable treatment option for AS patients, regardless of BMI."

Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis • IL17A