tesnatilimab (JNJ-64304500) / J&J - LARVOL DELTA

Biologic drugs for induction and maintenance of remission in Crohn's disease: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "This review has supported evidence generation, but head-to-head comparative trials for key interventional subclasses or specific agents may be needed, as guided by key stakeholders; for example, on the use of biosimilar versions of medications out of patent. The role of concomitant purine analogues is a key confounding factor and future studies may not only want to investigate specifically the role of combinations, but also consider stratifying populations or purposefully excluding participants based on this key class of therapy to avoid such heterogeneity. Given the majority of evidence focusses on the outcomes of clinical remission and relapse, future studies may want to further consider other outcomes of clear interest to clinicians and patients, particularly endoscopic remission. Finally, long-term safety data are limited throughout the networks. Whilst future studies with longer follow-ups could provide increased data, it may be that study designs outside of..."

Clinical • Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL7R

DUET: A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Janssen Research & Development, LLC | Phase classification: P2a ➔ P2

Phase classification • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology

TRIDENT: Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=388 | Completed | Sponsor: Janssen Research & Development, LLC | Phase classification: P2b ➔ P2

Phase classification • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

ARGESMAP: AN AI-DRIVEN MODEL TO ENHANCE ANATOMIC SEGMENT CLASSIFICATION OF GASTROINTESTINAL ENDOSCOPY VIDEOS IN CROHN’S DISEASE (DDW 2024) - P2b, P3b | " Endoscopic videos from two CD clinical trials were utilized to train an AI-based classifier for predicting anatomic segments per frame: SEAVUE (NCT03464136) a 5 -week phase 3b trial comparing ustekinumab versus adalimumab with 631 videos available from 371 subjects; and TRIDENT (NCT0 877134) a 4-week phase of JNJ-64304500 with 704 videos available from 38 subjects. The AI-based anatomic segment classification using ArgesMAP exhibited promising performance at both the frame- and patient-levels in validation using CD clinical trial data. This indicates that ArgesMAP has the potential to be integrated into clinical practice to identify and localize anatomic segments in CD videos leading to improved diagnosis and treatment planning for patients with CD. Future work will investigate the generalization of anatomic segment classification to other types of Inflammatory Bowel Disease such as Ulcerative Colitis for novel endpoint development."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Model-based Investigation of Inadequate Efficacy of Tesnatilimab, an Anti- Natural Killer Group 2 Member D (NKG2D) Monoclonal Antibody, in Moderately to Severely Active Crohn's Disease. (PubMed, J Clin Pharmacol) - "No apparent E-R relationships were observed for the investigated safety endpoints. The PopPK and E-R analysis indicated that the inadequate efficacy of tesnatilimab in CD was unlikely due to insufficient drug exposure and target engagement."

Clinical • Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • NKG2D

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study Evaluating the Safety and Efficacy of Tesnatilimab in Patients With Moderately to Severely Active Crohn's Disease. (PubMed, J Crohns Colitis) - "Tesnatilimab was well tolerated. The efficacy of tesnatilimab in patients with CD was significant for the primary endpoint in Part 1; however, no dose-response signal was detected for the primary endpoint in Part 2. Based on these inconsistent findings, tesnatilimab was not considered an effective treatment for patients with CD and no further development is planned."

Clinical • Journal • P2b data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • NKG2D

TRIDENT: Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=388 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Jan 2022

Trial completion • Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Janssen Research & Development, LLC; Initiation date: Mar 2021 ➔ May 2021

Clinical • Trial initiation date

A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants (clinicaltrials.gov) - P1; N=43; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed

Trial completion

A Study of JNJ-64304500 in Participants With Alopecia Areata (clinicaltrials.gov) - P2a; N=0; Withdrawn; Sponsor: Janssen Research & Development, LLC; N=50 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Alopecia

DUET: A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease (clinicaltrials.gov) - P2a; N=0; Withdrawn; Sponsor: Janssen Research & Development, LLC; N=70 ➔ 0; Recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology • CRP

A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Janssen Research & Development, LLC; N=20 ➔ 0; Recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal

A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants (clinicaltrials.gov) - P1; N=43; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

DUET: A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn’s Disease (clinicaltrials.gov) - P2a; N=70; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology • CRP

A Study of JNJ-64304500 in Participants With Alopecia Areata (clinicaltrials.gov) - P2a; N=50; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P2a trial • Alopecia

JNJ-64304500: Data from P2 TRIDENT trial (NCT02877134) for Crohn's disease in 2021 (J&J) - Q4 2020 Results

P2 data • Crohn's disease • Inflammatory Bowel Disease

A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial

A Study of JNJ-64304500 or Guselkumab in Adult Participants With Celiac Disease (clinicaltrials.gov) - P1b; N=80; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial • Celiac Disease • Immunology • CRP

A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants (clinicaltrials.gov) - P1; N=70; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial

DUET: A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease (clinicaltrials.gov) - P2a; N=70; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P2a trial • Colorectal Cancer • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Oncology • CRP

TRIDENT: Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b; N=389; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • Enrollment closed • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

JNJ-64304500: NME filing in US for Crohn's disease between 2020-2023 (J&J) - Pipeline Update: Regulatory submission in EU for Crohn's disease between 2020-2023

BLA • European regulatory • Crohn's disease • Inflammatory Bowel Disease

Efficacy of NNC 0142-0000-0002 in subjects with rheumatoid arthritis (RA) (clinicaltrials.gov) - P2, N=63; Recruiting -> Active not recruiting; N: 54 -> 63

Enrollment closed • Rheumatoid Arthritis