RG7835 / Roche - LARVOL DELTA

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC) (clinicaltrials.gov) - P1 | N=45 | Terminated | Sponsor: Hoffmann-La Roche | Phase classification: P1b ➔ P1

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

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - P2; N=2; Terminated; Sponsor: Hoffmann-La Roche; N=84 ➔ 2; Trial completion date: Mar 2024 ➔ Nov 2021; Active, not recruiting ➔ Terminated; Trial primary completion date: Mar 2024 ➔ Nov 2021; A lack of efficacy was seen with RO7049665 in a study of ulcerative colitis. This reduces the likelihood that the drug is effective in autoimmune hepatitis.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatology • Immunology • Inflammation

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - P2; N=84; Active, not recruiting; Sponsor: Hoffmann-La Roche; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Hepatology • Immunology • Inflammation

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC) (clinicaltrials.gov) - P1b; N=45; Terminated; Sponsor: Hoffmann-La Roche; N=65 ➔ 45; Trial completion date: Apr 2022 ➔ Jul 2021; Recruiting ➔ Terminated; Trial primary completion date: Apr 2022 ➔ Jul 2021; The decision to terminate study WP40161 is based on the lack of robust clinical improvement in the underlying condition after 8 weeks of treatment with RO7049665.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

"✅ History of AIH treatment ✅ Last (!) #RCT in #AIH was published in 2010 ✅ @Roche terminated RO7049665 RCT ✅ CAMARO (AZA vs MMF for induction) is recruiting in 🇳🇱 🇧🇪 ✅ 58/70 approaching completion @romeesnijders @CincyKidsCALD @LiverTrust @ERN_RARE_LIVER @bezerratweet" (@joostphdrenth)

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - P2; N=84; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Immunology

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - P2; N=84; Not yet recruiting; Sponsor: Hoffmann-La Roche

Clinical • New P2 trial • Hepatology • Immunology

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC) (clinicaltrials.gov) - P1b; N=65; Recruiting; Sponsor: Hoffmann-La Roche; N=50 ➔ 65; Trial completion date: Apr 2021 ➔ Apr 2022; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC) (clinicaltrials.gov) - P1b; N=50; Recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Mar 2020 ➔ Apr 2021; Trial primary completion date: Mar 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Immunology • Inflammatory Bowel Disease • Solid Tumor • Ulcerative Colitis

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers (clinicaltrials.gov) - P1; N=49; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting ➔ Completed

Clinical • Trial completion

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC) (clinicaltrials.gov) - P1b; N=50; Recruiting; Sponsor: Hoffmann-La Roche

Clinical • New P1 trial

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers (clinicaltrials.gov) - P1; N=49; Active, not recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Dec 2018 ➔ Apr 2019; Trial primary completion date: Dec 2018 ➔ Apr 2019

Clinical • Trial completion date • Trial primary completion date