Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01671956
• Date of registration: 09/08/2012
• Prospective Registration: Yes
• Primary sponsor: Immune Pharmaceuticals
• Public title: Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
• Scientific 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
• Date of first enrolment: July 2015
• Target sample size: 42
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT01671956
• 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

Israel

Contacts

• Name: Tony Fiorino, MD

• Name: Dov Wengrower, MD
• Affiliation: Shaare Zedek Medical Center, Jerusalem, Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males or females, 18 to 70 years of age inclusive.

2. Diagnosed with active moderate to severe UC per standard diagnostic criteria for a
minimum of 3 months:

- Mayo score of 6-12 (inclusive) at the Screening Visit

- Endoscopic evidence of active mucosal disease, as assessed by flexible
sigmoidoscopy, with an Endoscopic Finding Sub-score of =2 (assessed centrally)

- Rectal Bleeding Sub-score of =1

- Physician's Global Assessment (PGA) Sub-score of =2.

3. Levels of eotaxin-1 in biopsied colon tissue of =100 pg/mg protein.

4. Adequate cardiac, renal and hepatic function as determined by the Investigator and
demonstrated by screening laboratory evaluations and physical examination results;
these findings must all be within normal limits or judged not clinically significant
by the Investigator.

Exclusion Criteria:

1. History of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy.

2. Currently receiving total parenteral nutrition (TPN).

3. Positive Clostridium difficile toxin stool assay.

4. Tested positive for active/latent mycobacterium tuberculosis (TB) infection.

5. Pregnant or breast-feeding, or plan to become pregnant during the study.

6. Males who are young and childless or planning to have more children in the future.

7. Known hypersensitivity to bertilimumab or any of the drug excipients.

8. History of infection requiring administration of any IV antibiotic, antiviral or
antifungal medication within 30 days of Screening or any oral anti-infective agent
within 14 days of Screening.

9. Severe UC evidenced by the following signs of toxicity: heart rate >100 beats/min at
rest, temperature >37.8°C, hemoglobin <10.0 g/dL.

10. Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal
verge.

11. Received a vaccine or other immunostimulator within 4 weeks prior to screening.

12. Use of >4.8 g mesalazine or equivalent within 2 weeks prior to the screening visit.
Mesalazine =4.8 g is allowed if the dose during the 2 weeks prior to the screening
visit was stable.

13. Use of systemic corticosteroids exceeding the equivalent of 20 mg/day of prednisone
within four weeks prior to the screening visit (see Section 6.9.1).

14. Change in dose of immunosuppressive drugs (e.g., corticosteroids, 6-mercaptopurine
[6-MP], azathioprine) within four weeks prior to the screening visit.

15. Use of TNF-blockers (e.g., infliximab or adalimumab) within 60 days of the screening
visit.

16. Use of chronic non-steroidal anti-inflammatory (NSAID) therapy. Occasional use of
NSAIDs or acetaminophen for headache, arthritis, myalgias, menstrual cramps, etc., or
daily use of low dose (81-162 mg) aspirin for cardiovascular prophylaxis is allowed.

17. Patients diagnosed with:

- Crohn's disease

- Diverticulitis or diverticulosis

- Indeterminate colitis (inability to distinguish between UC and Crohn's disease
[as assessed by the Investigator])

- Microscopic colitis (collagenous or lymphocytic colitis)

- Ischemic or infectious colitis

- Clostridium difficile colitis within 90 days of the screening visit

- Parasitic disease within 90 days of the screening visit

- Systemic fungal infection within 90 days of the screening visit.

18. History of positive serology of hepatitis B or C, or human immunodeficiency virus
(HIV) infection.

19. Congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, organ
transplantation).

20. Clinically significant abnormal laboratory test results, unless regarded by the
Investigator as related to UC, including but not limited to:

- Hemoglobin level <10.0 g/dL

- White blood cell count < 3 x 103/µL

- Lymphocyte count < 0.5 x 103/µL

- Platelet count <100 x 103/µL or >1200 x 103/µL

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 the upper
limit of normal (ULN)

- Alkaline phosphatase >3 ULN

- Serum creatinine >2 ULN.

21. Active abuse of alcohol or drugs.

22. Known malignancy or history of malignancy that could reduce life expectancy.

23. Any condition, which in the opinion of the Investigator, would place the patient at an
unacceptable risk if participating in the study protocol.

24. Participation in a clinical trial of an investigational (unapproved) product



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis, Active Severe

Ulcerative Colitis, Active Moderate

Intervention(s)

Biological: Bertilimumab

Biological: Placebo

Primary Outcome(s)

Clinical response [Time Frame: Day 56]

Secondary Outcome(s)

Change in partial Mayo score from Day 0 to all scheduled measurement timepoints (efficacy follow up). [Time Frame: Throughout the study]

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 UCEIS score from screening to Day 56 [Time Frame: Da 56]

Secondary ID(s)

Immune/BRT/UC-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors