Clinical trial · Interventional
Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease
A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated for business reasons; not due to safety or efficacy concerns.
Summary
Brief summary (as posted)
A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brazikumab IV Infusion | Drug | — | UNRESOLVED |
| Brazikumab SC Injection | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
- interventionNames
- Drug: Brazikumab IV Infusion
- Drug: Brazikumab SC Injection
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Brazikumab High Dose
- description
- Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
- interventionNames
- Drug: Brazikumab IV Infusion
- Drug: Brazikumab SC Injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ileal, ileo-colonic, or colonic Crohn's Disease (CD) for \> 3 months prior to screening * Men or women age 18 - 80 years at the time of screening * Moderate to severely active CD, as defined by Crohn's Disease Activity Index (CDAI) and endoscopic demonstration of inflammation * Stable dose of medications for Crohn's disease therapy * Prior treatment failure or intolerance with at least one Anti-Tumor Necrosis Factor-Alpha Therapy (anti-TNF α) agent * Effective contraception from screening, and for 36 weeks after the last dose of investigational product * No known history of active tuberculosis (TB) \& negative assessment for TB/latent TB Exclusion Criteria: * Severe underlying immunosuppression * Severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation * Significant infections at screening; Infected abscess, positive for Clostridium difficile, recent infectious hospitalization * Recent treatment with approved or investigational biologic therapy for Crohn's disease * Recent or planned live attenuated vaccine * History of cancer, except for basal cell carcinoma or carcinoma in situ (CIS) of the cervix with apparent cure ≥ 12 months before screening * Pregnancy/breast feeding * Drug abuse
References
Publications (0)
Data not yet available