Phase 2
Completed N=111
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
Source: ClinicalTrials.gov NCT01482884 ↗Enrolled (actual)
111
Serious AEs
11.8%
Results posted
Apr 2016
Primary outcomePrimary: Clinical Response at Week 8 Based on Mayo Score — 37.5; 32.7 Percentage of responders — p=0.4062
Summary
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at Week 8 Based on Mayo Score |
37.5; 32.7 | 0.4062 |
| SECONDARY Change in Mayo Score From Baseline to Week 8 |
-2.41; -1.92 | 0.3937 |
| SECONDARY Mucosal Healing at Week 8 Based on Mayo Score |
32.1; 20.0 | 0.1043 |
| SECONDARY Clinical Remission at Week 8 Based on Mayo Score |
17.9; 5.5 | 0.0326 sig |
| SECONDARY Change From Baseline in Partial Mayo Score |
-1.8; -0.8; -2.4; -1.7; -2.7; -2.6 | — |
| SECONDARY Change From Baseline in Modified Riley Score |
-0.49; -0.74 | 0.4490 |
| SECONDARY Change From Baseline in C - Reactive Protein |
-2.755; 0.510; -1.089; 0.637; -2.795; -1.974 | — |
| SECONDARY Change From Baseline in Albumin |
0.0; -0.7; 0.8; -0.2; 0.3; -0.4 | — |
| SECONDARY Change From Baseline in Calprotectin |
69.45; 198.80; 86.47; -250.52; -39.19; 50.31 | — |
| SECONDARY Serum Concentration of Tralokinumab |
0.00; NA; 37.9; NA; 50.2; NA | — |
| SECONDARY Immunogenicity |
0; 1; 0; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed ulcerative colitis at least 90 days prior randomisation.
- Men or women age 18 - 75 years.
- Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
- Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.
Exclusion Criteria
- Pregnant or breastfeeding women.
- History of colostomy.
- Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
- Hepatitis B, C or HIV.
- History of cancer.
Data sourced from ClinicalTrials.gov (NCT01482884). 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. Informational only — not medical advice.