Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT01671956|
Recruitment Status : Recruiting
First Posted : August 24, 2012
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis, Active Moderate Ulcerative Colitis, Active Severe||Biological: Bertilimumab Biological: Placebo||Phase 2|
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult patients with active moderate to severe UC . Eligible patients will be randomly assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10 mg/kg or matching placebo, respectively.
The study will consist of three periods: a screening period of up to two weeks, a 4-week double-blind treatment period (three IV infusions at 2-week intervals), and a safety and efficacy follow-up period of approximately 9 weeks.
Bertilimumab is a recombinant human IgG4 monoclonal antibody that neutralizes human eotaxin-1 (eotaxin). Bertilimumab will be administered every other week for 4-weeks, by IV infusion over 30 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||March 2019|
Bertilimumab 10 mg/kg will be administered by IV infusion over 30 minutes
IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
Placebo Comparator: Placebo
Phosphate buffered saline (PBS) placebo will be administered by IV infusion over 30 minutes.
IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
- Clinical response [ Time Frame: Day 56 ]
- A decrease in Mayo score from baseline of at least 3 points and at least 30% AND
- Either a decrease in the sub-score for rectal bleeding of at least 1 point, or rectal bleeding sub-score of 0 or 1.
- Change in UCEIS score from screening to Day 56 [ Time Frame: Da 56 ]
- Clinical remission at Day 56, defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point [ Time Frame: Day 56 ]
- Mucosal healing at Day 56, defined as an absolute sub-score for endoscopy of 0 or 1. [ Time Frame: Day 56 ]
- Change in partial Mayo score from Day 0 to all scheduled measurement timepoints (efficacy follow up). [ Time Frame: Throughout the study ]
- PHARMACOKINETICS [ Time Frame: Throughout the study ]PK analysis for bertilimumab concentration: blood samples will be collected on dosing days (pre-dose and at 30 minutes and 4 hours following initiation of study drug infusion) and at the follow-up visits. The following PK parameters will be calculated, to the degree possible given the number of timepoints: Cmax, Tmax, Cavg, Cmin and t1/2. Additional standard and exploratory PK parameters will be calculated if deemed necessary
- PHARMACODYNAMIC [ Time Frame: Throughout the study ]
- Fecal calprotectin change from Day 0 (baseline) to all scheduled measurement timepoints.
- PD analysis of eosinophil shape change: blood samples will be collected on dosing days (pre-dose and on Day 0 only, at 4 hours following initiation of study drug infusion), and at the follow-up visits.
- Change in eosinophil count, serum eotaxin-1 and hs-CRP from Day 0 to all scheduled measurement timepoints.
- Change in eotaxin-1 concentration and eosinophil count in biopsy tissue from Screening to Day 56
- Safety [ Time Frame: Throughout the study ]
- Adverse events (AE)
- Injection site reactions
- Physical examination
- Vital signs (blood pressure, heart rate, temperature and respiratory rate)
- Concomitant medications
- Laboratory evaluation (hematology, biochemistry, anti-bertilimumab antibodies).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671956
|Contact: Tony Fiorino, MDfirstname.lastname@example.org|
|Contact: Brenda Kolatchemail@example.com|
|HaEmek Medical Center||Recruiting|
|Contact: Eran Zittan, MD|
|Contact: Ika Davidov|
|Wolfson Medical Center||Recruiting|
|Holon, Israel, 58100|
|Contact: Yona Avni, MD|
|Contact: Orit Shevah|
|Principal Investigator: Yona Avni, Dr|
|Shaare Zedek Medical Central||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Dov Wengrower, MD|
|Contact: Chava Kaniel|
|Principal Investigator: Dov Wengrower, Dr|
|Hadassah Ein Kerem||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Eran Israeli, MD|
|Contact: Galina Gerber|
|Meir Medical Center||Recruiting|
|Kfar-Saba, Israel, 44299|
|Contact: Fred Konikoff, MD|
|Contact: Lee Graidy|
|Sourasky-Ichilov Tel Aviv Medical Center||Recruiting|
|Tel- Aviv, Israel, 64239|
|Contact: Sigal Fishman, MD|
|Contact: Liana Shmialov|
|Principal Investigator: Sigal Fishman, Dr|
|Principal Investigator:||Dov Wengrower, MD||Shaare Zedek Medical Center, Jerusalem, Israel|