Clinical trial · Interventional
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy
NCT01714726CI-TRIAL-00051997completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn's Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI2070 | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- MEDI2070 iv infusion
- interventionNames
- Drug: MEDI2070
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo iv infusion
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- open-label
- description
- MEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. * Men or women age 18 - 65 years at the time of screening. * Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1. * No known history of active tuberculosis (TB). * Received at least one anti-TNFα agent for the treatment of CD and did not initially respond. Exclusion Criteria: * Pregnant or breastfeeding women. * Presence of ileostomy and/or colostomy. * Short bowel syndrome. * Bowel perforation or obstruction. * History of cancer.
References
Publications (2)
- BACKGROUNDSands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5. PMID 28390867
- DERIVEDDanese S, Beaton A, Duncan EA, Mercier AK, Neisen J, Seth H, Zetterstrand S, Sands BE. Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn's disease. BMC Gastroenterol. 2023 Dec 20;23(1):451. doi: 10.1186/s12876-023-03078-7. PMID 38124112