A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy

• Register: EUCTR
• Last refreshed on: 11 December 2017
• Main ID: EUCTR2015-000609-38-ES
• Date of registration: 08/02/2016
• Prospective Registration: Yes
• Primary sponsor: MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK
• Public title: A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy
• Scientific title: 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
• Date of first enrolment: 29/02/2016
• Target sample size: 342
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000609-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Slovakia, Slovenia, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: MedImmune Contact
• Affiliation: MedImmune

• Name: MedImmune Contact
• Affiliation: MedImmune

Key inclusion & exclusion criteria

Inclusion criteria:
-Diagnosis of ileal, ileo-colonic, or colonic 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 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-TNF? agent
-Effective contraception from screening, and for 26 weeks after the last dose of investigational product
-No known history of active tuberculosis (TB) & negative assessment for TB/latent TB
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 308
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

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 CIS of the cervix with apparent cure ? 12 months before screening
- Pregnancy/breast feeding
- Drug abuse


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease
MedDRA version: 18.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: MEDI2070
Product Code: MEDI2070
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Not assigned
CAS Number: 1610353-18-8
Current Sponsor code: MEDI2070
Other descriptive name: Anti-IL-23 monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Primary endpoint is CDAI remission at Week 8

Secondary Objective: To evaluate the efficacy of MEDI2070 to induce remission based on the SES-CD
To evaluate the efficacy of MEDI2070 to induce response based on the SES-CD
To evaluate the efficacy of MEDI2070 to induce remission based on the PRO2
To evaluate the efficacy of MEDI2070 to induce response based on the PRO2
To assess the safety and tolerability of MEDI2070
To evaluate the PK and IM of MEDI2070
To characterize MEDI2070?s dose-exposure & exposure-response relationships
To evaluate the efficacy of MEDI2070 to induce clinical response based on the CDAI
To evaluate the efficacy of MEDI2070 to induce clinical remission based on the CDAI
To evaluate the efficacy of MEDI2070 on modified sustained remission, based on the SES-CD
To evaluate the efficacy of MEDI2070 on modified sustained remission based on the PRO2
To evaluate the efficacy of MEDI2070 on modified sustained remission based on the CDAI
To assess the relationship of biomarker 1 & biomarker 2 to CDAI remission

Timepoint(s) of evaluation of this end point: Week 8

Main Objective: The primary objective of this study is to evaluate the efficacy of MEDI2070 versus placebo to induce clinical remission based on the CDAI score at Week 8 in subjects with moderate to severe CD who have failed or are intolerant to anti-TNF? therapy.

Secondary Outcome(s)

Secondary end point(s): Key secondary endpoints (Induction period):
SES-CD Remission
SES-CD Response
PRO2 Remission
PRO2 Response

Key secondary endpoints (Maintenance period):
CDAI remission
SES-CD Remission
PRO2 Remission
CDAI Modified sustained remission
SES-CD Modified sustained remission
PRO2 Modified sustained remission

Safety Endpoints
Incidence and severity of treatment-emergent adverse events (AEs)
Incidence of treatment-emergent serious AEs (SAEs)
Incidence and severity of treatment-emergent AEs of special interest, including:
Incidence and severity of infection-related AEs and SAEs
Incidence and severity of infusion/injection-site reactions
Incidence and severity of hypersensitivity reactions
Incidence of AEs leading to study drug discontinuation
Incidence of specific laboratory abnormalities
Incidence of malignancies
Presence of antidrug antibodies in serum to MEDI2070

Timepoint(s) of evaluation of this end point: Week 8, Week 16 Week 28 and Last study visit - Follow up 28 weeks post last study treatment

Secondary ID(s)

2015-000609-38-DE

D5170C00002

Source(s) of Monetary Support

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC