Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2024
Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04893707 (An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and Safety of IL-4Rα Inhibitors for Atopic Dermatitis: A Systematic Review and Meta Analysis of Randomised Controlled Trials.The Australasian journal of dermatology · 2026Pooled it
- Baseline Inflammatory Biomarkers and Disease Burden for Predicting Response to Stapokibart in CRSwNP.Diagnostics (Basel, Switzerland) · 2026Article
- Exploring the impact of IL-2 cytokine family on skin barrier function: pathophysiology and therapeutic strategies.Molecular biology reports · 2026Review
- Stapokibart's clinical effectiveness in treating moderate-to-severe bullous pemphigoid in the elderly.Frontiers in immunology · 2026Article
- A case report of IgA-mediated anti-Laminin-γ1 (p200) pemphigoid successfully treated with stapokibart combined with corticosteroids.Frontiers in immunology · 2026Article
- Immune and environmental predictors of disease severity in atopic dermatitis: a retrospective cohort study.American journal of translational research · 2026Article
- From Pathways to Patients in Atopic Dermatitis: Advanced Systemic Therapies.International journal of molecular sciences · 2025Review
- Article
- Evaluating stapokibart in the treatment of seasonal allergic rhinitis.Immunotherapy · 2025Review
- Stapokibart: First Approval.Drugs · 2025Review
- New and Emerging Biologics and Jak Inhibitors for the Treatment of Prurigo Nodularis: A Narrative Review.Medicina (Kaunas, Lithuania) · 2025Review
- Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.Journal of clinical medicine · 2025Review
- Targeting the IL-4/IL-4R Axis in Th2 Inflammatory Diseases: A Review of Clinical Efficacy and Safety.Journal of inflammation research · 2025Review
- Successful treatment of pityriasis lichenoides et varioliformis acuta with stapokibart: a case report.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStapokibart/CM310, a humanized monoclonal antibody targeting the interleukin-4 receptor α chain, has shown promising treatment benefits in patients with moderate-to-severe atopic dermatitis in previous phase II clinical trials.
objectiveWe aimed to evaluate the long-term efficacy and safety of stapokibart in adults with moderate-to-severe atopic dermatitis.
methodsEnrolled patients who previously completed parent trials of stapokibart received a subcutaneous stapokibart 600-mg loading dose, then 300 mg every 2 weeks up to 52 weeks. Efficacy outcomes included the proportions of patients with ≥ 50%/75%/90% improvements from baseline of parent trials in the Eczema Area and Severity Index, Investigator's Global Assessment, and weekly average of the daily Peak Pruritus Numerical Rating Scale.
resultsIn total, 127 patients were enrolled, and 110 (86.6%) completed the study. At week 52, the Eczema Area and Severity Index-50/75/90 response rates were 96.3%, 87.9%, and 71.0%, respectively. An Investigator's Global Assessment 0/1 with a ≥ 2-point reduction was achieved in 39.3% of patients at week 16, increasing to 58.9% at week 52. The proportions of patients with ≥ 3-point and ≥ 4-point reductions in the weekly average of daily Peak Pruritus Numerical Rating Scale scores were 80.2% and 62.2%, respectively, at week 52. Improvement in patients' quality of life was sustained over a 52-week treatment period. Treatment-emergent adverse events occurred in 88.2% of patients, with an exposure-adjusted event rate of 299.2 events/100 patient-years. Coronavirus disease 2019, upper respiratory tract infection, and conjunctivitis were the most common treatment-emergent adverse events.
conclusionsLong-term treatment with stapokibart for 52 weeks showed high efficacy and good safety profiles, supporting its use as a continuous long-term treatment option for atopic dermatitis. CLINICAL
trial registrationClinicalTrials.gov identifier: NCT04893707 (15 May, 2021).
Indexed as
Identifiers
39080181What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.