Moderate to Severe Ulcerative ColitisPhase 1NCT06693908
A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis
A Phase 1 study testing Vixarelimab in people with Moderate to Severe Ulcerative Colitis, run by Genentech, Inc. at 1 site in Germany.
Trial summary
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Ulcerative Colitis
- What is being tested?
- Vixarelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2025to 18 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of UC established at least 3 months
- Moderately to severely active UC
- Participants must meet criteria for either advanced therapy failure or conventional therapy failure
Who cannot join
- Diagnosis of Crohn's disease or indeterminate colitis
- Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
- Prior colectomy
- Prior treatment with systemic janus kinase (JAK) inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).
- Conditions
- Moderate to Severe Ulcerative Colitis
- Being tested
- Vixarelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VixarelimabDrug
Also called RO7622888; KPL-716
Vixarelimab will be administered as per the schedule specified.
| Study group | Role | What they receive |
|---|---|---|
| Vixarelimab | Experimental | Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period. Receives: Drug: Vixarelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fibroblast Products From Colonic Tissue
Measured: Baseline up to approximately 3 months
Secondary outcomes (3)
Serum Concentration of Vixarelimab
Measured: Up to approximately 3 months
Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab
Measured: Up to approximately 3 months
Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale
Measured: Up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start31 Mar 2025
- Primary completion13 Jul 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693908
- Sponsor's protocol ID
- GA45735
- Other IDs
- 2024-516287-29-00
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06693908
- Acronym / sponsor ID
- GA45735
- Conditions
- Moderate to Severe Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vixarelimab | Experimental | Drug: VixarelimabParticipants will receive subcutaneous (SC) injections of vixarelimab during the treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of UC established at least 3 months
- Moderately to severely active UC
- Participants must meet criteria for either advanced therapy failure or conventional therapy failure
Key exclusion criteria (4 listed)
- Diagnosis of Crohn's disease or indeterminate colitis
- Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
- Prior colectomy
- Prior treatment with systemic janus kinase (JAK) inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VixarelimabAlso: RO7622888; KPL-716Vixarelimab will be administered as per the schedule specified. | Drug | Vixarelimab |
Primary outcome
Change From Baseline in Fibroblast Products From Colonic Tissue
Time frame: Baseline up to approximately 3 months
3 secondary outcomes
Serum Concentration of Vixarelimab
Time frame: Up to approximately 3 months
Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab
Time frame: Up to approximately 3 months
Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale
Time frame: Up to approximately 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vixarelimab in people with Moderate to Severe Ulcerative Colitis, run by Genentech, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Fibroblast Products From Colonic Tissue (time frame: Baseline up to approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.