cendakimab (CC-93538) / AbbVie, BMS - LARVOL DELTA

ERIM-EoE: A Novel Coupled Integro-Differential Dynamical Systems Framework With Optimal Control for Personalized Biologic Selection, Dosing, and Dilation Timing in Eosinophilic Esophagitis (ACG 2026) - "Calibration achieved excellent fit (cost=1.067; cross-validation RMSE: E=0.207, B=0.299, R=0.162 for dupilumab). Estimated β: dupilumab 0.98, benralizumab 0.90, cendakimab 0.72. Sensitivity analysis revealed δ (eosinophil clearance; PRCC=â0.818) and ν (barrier repair; PRCC=+0.422) as dominant drivers."

Eosinophilic Esophagitis • Fibrosis • Gastrointestinal Disorder • Immunology • Inflammation • IL13

Dose-Response and Time-Course Dynamics of Biologics in Eosinophilic Esophagitis: A Model-Based Network Meta-Analysis (ACG 2026) - "Sixteen trial arms across seven classes (dupilumab, cendakimab, mepolizumab, budesonide orodispersible tablet, fluticasone, proton pump inhibitors, and reslizumab) were analyzed. Dupilumab dose-response modeling revealed Emax 88.6%, ED50 1.0 mg, and γ 0.10, indicating near-maximal efficacy at clinical doses with limited gain beyond 100 mg. Increasing from 100 to 300 mg added only 2.3% additional response. Time-course modeling (300 mg weekly) estimated ET50 17.8 weeks, with predicted remission rates of 36% (week 8), 45% (week 12), 62% (week 24), and 80% (week 52), closely matching observed trial data (week 24: 59-60%; week 52: 84.6%)."

Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Evaluation of the Effect of Cendakimab on the Pharmacokinetics of CYP Probe Drugs in Patients With Eosinophilic Esophagitis. (PubMed, Clin Transl Sci) - "Patients received a cocktail of probe substrates (caffeine 200 mg, warfarin 10 mg + vitamin K 10 mg, omeprazole 40 mg, dextromethorphan 30 mg, midazolam 5 mg) for cytochrome P450 1A2, 2C9, 2C19, 2D6, and 3A in two sequential periods, separated by 16 weeks of cendakimab treatment. No clinically relevant changes in laboratory tests, vital signs, or electrocardiograms were observed. Cendakimab had no clinically meaningful effects on cytochrome P450 enzyme activities and was generally safe and well tolerated with or without probe substrates in adults with active eosinophilic esophagitis."

Journal • PK/PD data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • IL13

Cendakimab for Eosinophilic Gastritis and Duodenitis in Japanese Adults and Adolescents: Results From a Phase 3 Randomized Controlled Trial. (PubMed, Am J Gastroenterol) - "These findings highlight IL-13 inhibition as a potential treatment strategy for EG/EoD."

Clinical • Journal • P3 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Inflammation • IL13

Efficacy of Biological and Steroid Therapies in Adolescent and Adult Patients with Eosinophilic Esophagitis: A Systematic Review and Network Meta-Analysis with Meta-regression. (PubMed, Clin Gastroenterol Hepatol) - "All evaluated therapies except etrasimod achieved histologic remission, while only dupilumab, cendakimab, BOS, and BOT were associated with symptomatic improvement in EoE, highlighting dissociations between histologic and symptomatic responses. Most corticosteroid trials were short-term and lacked direct comparisons with biologics. Robust head-to-head trials are needed to define optimal treatment strategies, assess long-term outcomes, and clarify the role of symptom, endoscopic, and histologic endpoints in therapeutic decision-making."

Journal • Retrospective data • Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis (clinicaltrials.gov) - P3 | N=367 | Completed | Sponsor: Celgene | Active, not recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Aug 2025

Trial completion • Trial completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Ocular Adverse Events of Biologic Therapies Targeting the IL-4/IL-13 Pathway in Atopic Dermatitis: A Systematic Review and Meta-analysis (AAD 2026) - "Biologic therapies targeting the IL-4/IL-13 pathway, including dupilumab, tralokinumab, and lebrikizumab, have transformed management but raised concerns about ocular adverse events, particularly conjunctivitis. With emerging agents such as cendakimab and rademikibart, the true incidence of these events remains uncertain...In contrast, the risk of keratitis was not increased (0.41% vs 0.21%; RR, 1.14; 95% CI, 0.34–3.83;​​p=0.83; I²=0%), Similarly, keratoconjunctivitis did not differ significantly between groups (0.28% vs 0.11%; RR, 1.65; 95% CI, 0.34–7.98; p=0.53; I²=0%). Conclusion This meta-analysis suggests that treatment with IL-4/IL-13 inhibitors is associated with an increased risk of conjunctivitis in patients with atopic dermatitis, while no association was observed with keratitis or keratoconjunctivitis.."

Adverse events • Retrospective data • Review • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dry Eye Disease • Immunology • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • IL13 • IL4

Pruritic rash secondary to an investigational IL-13 inhibitor (AAD 2026) - "Clinical presentation and histology findings raised particular concern for CTCL, paralleling reports of increased CTCL risk in patients taking dupilumab, a monoclonal antibody inhibiting both IL-4 and IL-13 (1). Cendakimab is an anti-IL-13 monoclonal antibody under investigation as a treatment for atopic dermatitis and eosinophilic esophagitis. This case highlights a novel drug reaction secondary to cendakimab that histologically mimicked CTCL and demonstrates the value of biopsy and T-cell clonality testing in distinguishing drug-induced dermatitis from CTCL."

Atopic Dermatitis • Cardiovascular • Cutaneous T-cell Lymphoma • Dermatitis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Hypertension • Immunology • Pruritus • CD4 • CD7 • CD8 • IL13 • IL4

Pruritic rash secondary to cendakimab, an investigative IL-13 inhibitor. (PubMed, JAAD Case Rep) - No abstract available

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • IL13

Latent Variable Indirect Response Modeling of Cendakimab Exposure-Response for Longitudinal Dysphagia Days Using a Combined Uniform-Binomial Likelihood Framework. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Steroid IR/I and baseline DD influenced treatment response magnitude but did not warrant dose modification. These findings support QW-to-Q2W as an effective maintenance posology and the utility of latent variable IDR models with appropriate likelihoods for modeling bounded, discrete longitudinal endpoints in E-R analyses."

Clinical • Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Inflammatory and fibrotic biomarkers in patients with atopic dermatitis treated with cendakimab. (PubMed, J Allergy Clin Immunol Glob) - P2 | "Compared with placebo, cendakimab resulted in significantly greater reductions in these biomarker levels through week 16. Cendakimab decreased levels of key inflammatory and fibrotic biomarkers over 16 weeks of treatment in patients with moderate-to-severe AD."

Biomarker • Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Fibrosis • Immunology • Inflammation • CCL18 • CCL27 • IL13 • IL18 • POSTN

Monoclonal Antibodies' Efficacy on Dysphagia Symptoms and Histological Remission in Patients With Eosinophilic Esophagitis: A Systematic Review and Network Meta-Analysis (ACG 2025) - "We included 5 studies, with 1 study reporting 2 independent trials. Consequently, 6 RCTs comprising 631 patients were included in the final analysis. All RCTs compared monoclonal antibodies with a placebo, with 145 patients treated with dupilumab, 103 received benralizumab, 32 received mepolizumab, 34 received RPC4046, and 317 individuals assigned to the placebo group."

Retrospective data • Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • IL13 • IL4 • IL5

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis (clinicaltrials.gov) - P3 | N=48 | Completed | Sponsor: Celgene | Active, not recruiting ➔ Completed

Trial completion • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder

Cendakimab (Anti-IL-13) administration improves esophageal gene expression in eosinophilic esophagitis. (PubMed, J Allergy Clin Immunol) - P2 | "Cendakimab treatment normalizes the aberrant esophageal gene expression seen in patients with EoE, and the changes in transcripts correlate with histologic and endoscopic improvements. The finding that cendakimab corrects esophageal transcript expression even in endoscopic non-responders suggests that the IL-13 pathway is driving EoE pathogenesis in most patients. These collective findings, derived from a multisite, double-blinded, placebo-controlled trial, add molecular evidence that IL-13 drives EoE pathogenesis."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • CPA3 • IL13 • POSTN • TPSAB1 • TPSB2

Cendakimab in Adults and Adolescents with Eosinophilic Esophagitis. (PubMed, NEJM Evid) - P3 | "Cendakimab demonstrated statistically significant improvements in symptoms, histologic response, and endoscopic features of EoE versus placebo; the adverse-event and side-effect profile was not dose limiting. (Funded by Bristol Myers Squibb; ClinicalTrials.gov number, NCT04753697.)."

Clinical • Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • IL13

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis (clinicaltrials.gov) - P3 | N=368 | Active, not recruiting | Sponsor: Celgene | N=259 ➔ 368 | Trial primary completion date: Jun 2026 ➔ Aug 2025

Enrollment change • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review. (PubMed, Healthcare (Basel)) - "For CeD, therapies like gluten-degrading enzymes (latiglutenase, Kuma030) and zonulin inhibitors (larazotide acetate) show promise, though clinical outcomes are inconsistent...Transglutaminase 2 inhibitors like ZED-1227 could help prevent gluten-induced damage. Monoclonal antibodies targeting immune pathways, such as AMG 714 and larazotide acetate, require further validation in pediatric populations. In EoE, biologics like dupilumab, cendakimab, dectrekumab (IL-13 inhibitors), and mepolizumab, reslizumab, and benralizumab (IL-5/IL-5R inhibitors) show varying efficacy, while thymic stromal lymphopoietin (TSLP) inhibitors like tezepelumab are also being investigated...For IBD, biologics like vedolizumab, ustekinumab, and risankizumab, as well as small molecules like tofacitinib, etrasimod, and upadacitinib, are emerging treatments...Personalized therapy, integrating precision medicine, therapeutic drug monitoring, and lifestyle changes, is increasingly guiding pediatric..."

Journal • Review • Autoimmune Hepatitis • Celiac Disease • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • IL13 • IL5 • TGM2 • TSLP

EFFICACY AND SAFETY OF MONOCLONAL ANTIBODIES IN THE TREATMENT OF EOSINOPHILIC ESOPHAGITIS: A SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS (DDW 2025) - "Monoclonal antibodies such as benralizumab, cendakimab, and dupilimumab demonstrate superior efficacy in achieving a histologic response in eosinophilic esophagitis compared to placebo, with cendakimab showing the highest response rate. However, the safety profile varies, with lower risks of adverse events associated with mepolizumab and cendakimab, suggesting a need for individualized treatment strategies."

Retrospective data • Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

Pharmacokinetic Characterization of Cendakimab Administered with Different Devices and at Different Injection Sites in Healthy Participants. (PubMed, Eur J Drug Metab Pharmacokinet) - P1 | "PK parameters of cendakimab were comparable when using PFS or AI. Cendakimab exposures when administered in the arm or thigh resulted in similar exposure; both were ~ 20% higher than when administering in the abdomen. Both PFS and AI were well tolerated. ADA status did not impact the PK or safety of cendakimab."

Journal • PK/PD data

CENDAKIMAB REVERSES THE BIOMARKERS REPRESENTING FIBROTIC TISSUE REMODELING IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: RESULTS FROM A PHASE 3 TRIAL (DDW 2025) - P3 | "As also observed in the phase 2 HEROES trial, CEN significantly reversed EMT and fibrosis biomarkers in this phase 3 trial."

Biomarker • Clinical • P3 data • Eosinophilic Esophagitis • Fibrosis • Gastrointestinal Disorder • Immunology • CDH1 • IL13 • VIM

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis (clinicaltrials.gov) - P3 | N=48 | Active, not recruiting | Sponsor: Celgene | Trial completion date: Nov 2026 ➔ Sep 2025

Trial completion date • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder

CENDAKIMAB TREATMENT OF HUMAN ESOPHAGEAL FIBROBLASTS INHIBITS IL-13 INDUCED PATHOGENESIS (DDW 2025) - "Our data demonstrate that cendakimab has protective effects in primary healthy and EoE esophageal fibroblasts for both cytokine production and pro-fibrotic factors. Both IL-13Ra1 and IL-13Ra2 appear functional for mediating the effects of IL-13 on fibroblasts."

Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • IL13 • IL4R • IL6

CENDAKIMAB IS AN EFFECTIVE AND SAFE TREATMENT FOR PATIENTS WITH EOSINOPHILIC ESOPHAGITIS REGARDLESS OF INTERLEUKIN 13 VARIATIONS: RESULTS FROM A PHASE 3 TRIAL (DDW 2025) - P3 | "IL-13 SNP genotypes did not significantly impact efficacy or safety from the respiratory infection standpoint, suggesting that cendakimab is effective and safe in patients with EoE, regardless of the target variations."

Clinical • P3 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Infectious Disease • Respiratory Diseases • IL13

CENDAKIMAB EFFICACY AND SAFETY IN JAPANESE ADULTS AND ADOLESCENTS WITH EOSINOPHILIC GASTROENTERITIS: 16-WEEK RESULTS FROM THE RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 TRIAL (DDW 2025) - P3 | No abstract available

Clinical • P3 data • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis (clinicaltrials.gov) - P3 | N=48 | Active, not recruiting | Sponsor: Celgene | Trial primary completion date: Dec 2023 ➔ Jul 2024

Trial primary completion date • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder