Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01714726
• Date of registration: 24/10/2012
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
• Scientific title: 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
• Date of first enrolment: February 1, 2013
• Target sample size: 121
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01714726
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, Czech Republic, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United States

Contacts

• Name: Carl Gommoll, MS
• Affiliation: Allergan

Key inclusion & exclusion 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-TNFa 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: MEDI2070

Drug: placebo

Primary Outcome(s)

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period [Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period [Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)]

Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period [Time Frame: Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8]

Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period [Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)]

Number of Participants With TEAEs in Open-label Period [Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)]

Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period [Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)]

Percentage of Participants With CDAI Response at Week 12 [Time Frame: Week 12]

Percentage of Participants With CDAI-100 Point Improvement at Week 8 [Time Frame: Week 8]

Percentage of Participants With CDAI Remission at Week 8 [Time Frame: Week 8]

Change From Baseline in CDAI Total Score at Week 8 [Time Frame: Week 8]

Maximum Mean Serum Concentration of MEDI2070 in Open-label Period [Time Frame: Pre-dose on Weeks 12, 24, and 112]

Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period [Time Frame: Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)]

Number of Participants With ADA Positive to MEDI2070 in Open-label Period [Time Frame: Up to 28 week post last dose (approximately 140 weeks)]

Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period [Time Frame: From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)]

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period [Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)]

Number of Participants With TESAEs in Open-label Period [Time Frame: From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)]

Percentage of Participants With CDAI-70 Point Improvement at Week 8 [Time Frame: Week 8]

Secondary ID(s)

2012-004098-26

D5170C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01714726