golimumab/guselkumab (JNJ-4804) / J&J - LARVOL DELTA

Efficacy and Safety of the First Co-Antibody Therapy, JNJ-78934804, in Patients With Moderately to Severely Active Crohn's Disease Refractory to 2 or More Systemic Therapy Mechanisms (ACG 2026) - "In pts with CD refractory to â¥2 ST mechanisms, those receiving high-dose JNJ-4804 showed clinically meaningful improvements in W48 CR and endoscopic response vs GOL (Î27.3 and Î21.2, respectively), GUS (Î21.2, Î11.7), and PBO (Î39.4, Î35.0; Figure ), with efficacy across key endpoints exceeding both monotherapies. Mean change from baseline at W48 in fecal calprotectin was also greater with high-dose JNJ-4804 vs the other groups ( Figure ). Exposure-adjusted safety event rates with JNJ-4804 in the subpopulation were overall similar to or lower than PBO, GOL, or GUS ( Table )."

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • IL12A • IL23A

Beyond the Label? Real-World Dosing Strategies for Newer Biologic Therapies in Ulcerative Colitis (ACG 2026) - "The following are considered unique advanced therapies: adalimumab, etrasimod, golimumab, guselkumab, infliximab, mirikizumab, risankizumab, ustekinumab (includes biosimilars), upadacitinib, vedolizumab, tofacitinib, ozanimod assessed 12-months prior to index date...on-label refers to FDA label maintenance dosing: Q2W (vedolizumab [subcutaneous]), Q4W (mirikizumab) and Q8W (ustekinumab, risankizumab, vedolizumab [intravenous])... The maintenance cohorts comprised patients receiving USTE (n=7641), MIRI (n=322), RISA (n=707), and VEDO (n=15167) ( Table 1 ). Patients with â¥2 unique advanced therapies within 12 mo prior to index drug were 13.4% in MIRI, 10.9% in RISA, 7.1% in USTE and 1.7% in VEDO cohorts. During the maintenance period, most fills occurred at the on-label dosing interval for each therapy."

Clinical • Real-world • Real-world evidence • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL23A

EFFICACY AND SAFETY OF THE FIRST CO-ANTIBODY THERAPY, JNJ-78934804, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS REFRACTORY TO TWO OR MORE SYSTEMIC THERAPY MECHANISMS (UEGW 2026) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY AND SAFETY OF THE FIRST CO-ANTIBODY THERAPY, JNJ-78934804, IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE REFRACTORY TO TWO OR MORE SYSTEMIC THERAPY MECHANISMS (UEGW 2026) - No abstract available

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

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2b | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2029 ➔ Sep 2030

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=703 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2031 ➔ Nov 2029

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2030 ➔ Mar 2029

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Oct 2030

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2029 ➔ Oct 2030

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2024 ➔ Dec 2028

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2b | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2030 ➔ Oct 2033

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2030 ➔ Oct 2031

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2029 ➔ Mar 2029

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=577 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2024 ➔ Dec 2024

Combination therapy • Enrollment open • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=703 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Jan 2031

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Oct 2029

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2029 ➔ Aug 2029

Combination therapy • Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2030 ➔ Mar 2029

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2033 ➔ Feb 2029

Combination therapy • Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=703 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jul 2024 ➔ May 2025

Combination therapy • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P2b ➔ P2

Combination therapy • Phase classification • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUET-CD: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2b | N=715 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2028 ➔ Dec 2029

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

DUET-UC: A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=550 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2029 ➔ Aug 2030 | Trial primary completion date: Aug 2024 ➔ May 2025

Combination therapy • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis