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Monoclonal Antibodies
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new medication called UTTR1147A to see if it is safe and can be tolerated over a long period. It focuses on people with moderate to severe ulcerative colitis or Crohn's disease. The goal is to find a treatment that can help manage symptoms and improve their quality of life.
Eligible Conditions
- Colitis
- Crohn's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events
Side effects data
From 2021 Phase 2 trial • 396 Patients • NCT043866168%
Constipation
7%
Anaemia
7%
Hypokalaemia
6%
Hypertension
5%
Headache
5%
COVID-19 pneumonia
5%
Hypotension
4%
Anxiety
3%
Dry skin
3%
Respiratory failure
2%
Nausea
2%
Hypoxia
2%
Pneumonia
2%
Pneumothorax
2%
Multiple organ dysfunction syndrome
2%
Acute kidney injury
2%
Atrial fibrillation
2%
Gastric ulcer haemorrhage
2%
Acute myocardial infarction
2%
COVID-19
2%
Septic shock
1%
Renal impairment
1%
Urinary tract infection
1%
Respiratory distress
1%
Cardiac failure
1%
Urosepsis
1%
Pneumonia bacterial
1%
Liver injury
1%
Shock haemorrhagic
1%
Respiratory arrest
1%
Shock
1%
Radius fracture
1%
Haematuria
1%
Pneumomediastinum
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Pleural effusion
1%
Cardiac arrest
1%
Left ventricular failure
1%
Aspartate aminotransferase increased
1%
Right ventricular dysfunction
1%
Uterine leiomyoma
1%
Toxic encephalopathy
1%
Confusional state
1%
Oxygen saturation decreased
1%
Hypernatraemia
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
MSTT1041A
UTTR1147A
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: UTTR1147AExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UTTR1147A
2018
Completed Phase 2
~740
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,565 Previous Clinical Trials
569,913 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,150 Total Patients Enrolled