NCT04790916 is a Phase 2 clinical trial of RO7049665 in Autoimmune Hepatitis, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT04790916?

NCT04790916 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT04790916?

Interventions in NCT04790916: RO7049665, Placebo.

What condition does NCT04790916 study?

NCT04790916 studies Autoimmune Hepatitis, Autoimmune Chronic Hepatitis.

Is NCT04790916 still recruiting?

NCT04790916 is currently terminated. Last updated 18 September 2023.

Are results published for NCT04790916?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-18 · How we verify

NCT04790916

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)

Terminated Phase 2 Results posted Last updated 18 September 2023

What this trial tests

Phase 2 trial testing RO7049665 in Autoimmune Hepatitis in 2 participants. Terminated before completion.

Timeline

19 April 2021

Primary endpoint
18 November 2021

18 November 2021

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	2
Start date	19 April 2021
Primary completion	18 November 2021
Estimated completion	18 November 2021
Sites	14 locations across Italy, Netherlands, United Kingdom, Germany, South Korea, Canada, Australia, Portugal

Drugs / interventions tested

RO7049665 — full drug profile →
Placebo

Conditions studied

Autoimmune Hepatitis — all drugs for Autoimmune Hepatitis →
Autoimmune Chronic Hepatitis — all drugs for Autoimmune Chronic Hepatitis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 75, any sex, with Autoimmune Hepatitis or Autoimmune Chronic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539
IL-2-based approaches to Treg enhancement.
Harris F, Berdugo YA, Tree T. · · 2023 · cited 81× · PMID 36399073 · DOI 10.1093/cei/uxac105
"IL-2 immunotherapy for targeting regulatory T cells in autoimmunity".
Lykhopiy V, Malviya V, Humblet-Baron S, Schlenner SM. · · 2023 · cited 61× · PMID 37741949 · DOI 10.1038/s41435-023-00221-y
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases.
Tomasovic LM, Liu K, VanDyke D, Fabilane CS, et al · · 2024 · cited 17× · PMID 37999893 · DOI 10.1007/s40259-023-00635-0

Verify or expand the search:

Other trials of RO7049665

Trials testing the same drug.

NCT03943550 — Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerat · Phase 1 · terminated
NCT03221179 — Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Autoimmune Hepatitis

Currently open trials in the same condition.

NCT06381453 — Belimumab in Autoimmune Hepatitis · Phase 2 · recruiting
NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients · Phase 1 · recruiting
NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
NCT06250309 — Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients · NA · recruiting
NCT06078098 — Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04790916 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 18 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04790916.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing