Phase 2
N=195
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03558152 ↗Enrolled (actual)
195
Serious AEs
2.6%
Results posted
Apr 2023
Primary outcome: Primary: Percentage of Participants With Clinical Remission at Week 8 — 5; 4; 5; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- UTTR1147A (Drug); UTTR1147A Placebo (Drug); Vedolizumab (Drug); Vedolizumab Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Remission at Week 8 |
5; 4; 5; 11; 2; 38 | — |
| SECONDARY Percentage of Participants With Sustained Remission |
4.55; 0.00; 0.00; 8.70; 4.55; 4.76 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of UTTR1147A |
449; 590; 837; 426; 693; 1340 | — |
| SECONDARY Minimum Serum Concentration (Cmin) of UTTR1147A |
12.6; 28.3; 40.6; 15.8; 37.2; 44.5 | — |
| SECONDARY Percentage of Participants With Clinical Response at Week 8 |
30.23; 36.36; 20.93; 53.49; 36.36 | — |
| SECONDARY Percentage of Participants With Clinical Response at Week 30 |
9.09; 4.76; 4.76; 13.04; 0.00; 4.76 | — |
| SECONDARY Percentage of Participants With Endoscopic Healing at Week 8 |
13.95; 13.64; 11.63; 32.56; 13.64 | — |
| SECONDARY Percentage of Participants With Endoscopic Healing at Week 30 |
13.64; 9.52; 14.29; 13.04; 4.55; 19.05 | — |
| SECONDARY Percentage of Participants With Endoscopic Remission at Week 8 |
4.65; 0.00; 4.65; 11.63; 0.00 | — |
| SECONDARY Percentage of Participants With Endoscopic Remission at Week 30 |
9.09; 4.76; 4.76; 13.04; 0.00; 4.76 | — |
| SECONDARY Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score |
-4.14; -6.39; -3.56; -6.23; -4.95 | — |
| SECONDARY Change From Baseline in UC Bowel Movement Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score |
-5.66; -3.62; -9.63; -6.63; -12.0; -5.44 | — |
| SECONDARY Change From Baseline in UC Abdominal Signs and Symptoms at Week 8, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score |
-0.96; -1.83; -1.82; -1.69; -1.15 | — |
| SECONDARY Change From Baseline in UC Abdominal Signs and Symptoms at Week 30, as Assessed by Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Score |
-1.76; -0.64; -1.98; -1.05; -4.05; -1.82 | — |
| SECONDARY Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 |
31.85; 31.95; 25.16; 44.85; 27.05 | — |
| SECONDARY Change From Baseline in Patient-Reported Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 30 |
45.13; 35.50; 41.00; 41.38; 72.33; 55.43 | — |
| SECONDARY Percentage of Participants With Adverse Events |
12; 11; 15; 6; 4; 1 | — |
| SECONDARY Percentage of Participants With Presence of Anti-Drug Antibodies (ADA) at Baseline and After Drug Administration |
0; 2; 1; 1; 2; 1 | — |
Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of UC
- Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
- Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment
- Use of highly effective contraception as defined by the protocol
Exclusion Criteria
- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
- History of cancer as defined by the protocol
- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
- Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
- History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
- Prior treatment with UTTR1147A
- Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
- Prior treatment with rituximab
- Use of prohibited therapies, as defined by the protocol, prior to randomization
- Congenital or acquired immune deficiency
- Evidence or treatment of infections or history of infections, as defined by the protocol
Data sourced from ClinicalTrials.gov (NCT03558152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.