Phase 2
Completed N=119
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
Source: ClinicalTrials.gov NCT01714726 ↗Enrolled (actual)
119
Serious AEs
13.5%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8 — 26.7; 49.2 Percentage of Participants — p==0.01
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8 |
26.7; 49.2 | =0.01 sig |
| SECONDARY Percentage of Participants With CDAI-70 Point Improvement at Week 8 |
46.7; 52.5 | — |
| SECONDARY Percentage of Participants With CDAI Response at Week 12 |
28.3; 37.3 | — |
| SECONDARY Percentage of Participants With CDAI Remission at Week 8 |
15; 27.1 | — |
| SECONDARY Percentage of Participants With CDAI-100 Point Improvement at Week 8 |
25.0; 45.8 | — |
| SECONDARY Change From Baseline in CDAI Total Score at Week 8 |
-62.7; -99.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period |
41; 40 | — |
| SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period |
5; 5 | — |
| SECONDARY Number of Participants With TEAEs in Open-label Period |
44; 43 | — |
| SECONDARY Number of Participants With TESAEs in Open-label Period |
8; 12 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period |
2; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period |
5; 5; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period |
0; 0 | — |
| SECONDARY Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period |
0; 0 | — |
| SECONDARY Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period |
NA; 186; NA; 37.4; NA; 209 | — |
| SECONDARY Maximum Mean Serum Concentration of MEDI2070 in Open-label Period |
NA; 16.7; 14.5; 15.1; 18.3; 22.4 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period |
0; 1 | — |
| SECONDARY Number of Participants With ADA Positive to MEDI2070 in Open-label Period |
1; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01714726). 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.