A Phase 2 interventional study of UTTR1147A in Ulcerative Colitis and Crohn's Disease, sponsored by Genentech, Inc.. Terminated at 57 sites in 14 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 143 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria for Study Entry:
Inclusion Criteria for Study Entry and Study Re-Entry:
Exclusion Criteria:
Exclusion Criteria for Study Entry:
Exclusion Criteria for Study Entry and Study Re-Entry:
Exclusion Criterion for Study Re-Entry:
All participants will have the opportunity to receive treatment with UTTR1147A until clinical remission is achieved. Participants will either receive treatment with UTTR1147A or undergo observation depending on disease status, as described in the protocol.
Drug: UTTR1147A
UTTR1147A will be administered based on disease status, as described in the protocol.
Also known as: Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc
Number of Participants With Adverse Events
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)
Time frame: Up to 2 years
All 143 patients were included in the intent-to-treat (ITT) population, with 128 patients allocated to study treatment and 15 patients that were not treated.
| Milestone | UTTR1147A |
|---|---|
| Started | 143 |
| Completed | 82 |
| Not completed | 61 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 17 |
| Withdrew: Other | 9 |
| Withdrew: Physician decision | 2 |
| Withdrew: Study terminated by sponsor | 16 |
| Withdrew: Withdrawal by subject | 16 |
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Scale (NCI CTCAE v4.0)
| Participants | UTTR1147A |
|---|---|
| Serious Adverse Events, Fatal SAEs and SAEs Related to Study Medication | 9 |
| Non-Serious Adverse Events Reported | 52 |
Collected over From baseline up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UTTR1147A 60 | 0/128 (0%) | 9/128 (7%) | 52/128 (40.6%) |
| Event | UTTR1147A 60 |
|---|---|
| Lipase increasedInvestigations | 3/128 |
| Colitis ulcerativeGastrointestinal disorders | 2/128 |
| Amylase increasedInvestigations | 2/128 |
| AnaemiaBlood and lymphatic system disorders | 1/128 |
| Arteriosclerosis coronary arteryCardiac disorders | 1/128 |
| CataractEye disorders | 1/128 |
| COVID-19 pneumoniaInfections and infestations | 1/128 |
| Clostridium difficile infectionInfections and infestations | 1/128 |
| Venous thrombosis limbVascular disorders | 1/128 |
| Event | UTTR1147A 60 |
|---|---|
| Dry skinSkin and subcutaneous tissue disorders | 30/128 |
| AnaemiaBlood and lymphatic system disorders | 15/128 |
| COVID-19Infections and infestations | 10/128 |
| HeadacheNervous system disorders | 8/128 |
| PruritusSkin and subcutaneous tissue disorders | 8/128 |
There was only 1 arm in this study. The protocol was written with this single group receiving treatment based upon remission status.
| Age, Categorical(Participants) | UTTR1147A |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 135 |
| >=65 years | 8 |
| Age, Continuous(Years) | UTTR1147A |
|---|---|
| Mean | 41.5 ± 12.4 |
| Sex: Female, Male(Participants) | UTTR1147A |
|---|---|
| Female | 39 |
| Male | 104 |
| Race (NIH/OMB)(Participants) | UTTR1147A |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 142 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | UTTR1147A |
|---|---|
| Not Hispanic or Latino | 142 |
| Not Stated | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.