BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2016-000612-14-DE
• Date of registration: 05/09/2016
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim International GmbH
• Public title: BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.
• Scientific title: BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity.
• Date of first enrolment: 18/01/2017
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000612-14
• 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: yes; Other trial design description: At Week 24, patients initially randomized to EU-approved Humira will switch to receive BI 695501.; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: EU-marketed Humira®; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belarus, Bosnia and Herzegovina, Croatia, Czech Republic, European Union, Germany, Greece, Israel, Russian Federation, Serbia, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Males and females aged =18 and =80 years who have a diagnosis of moderate to severely active CD, confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:
a. CDAI score of =220 and =450
b. A diagnosis of CD confirmed by ileocolonoscopy during Screening
c. Presence of mucosal ulcers in at least one segment of the ileum or
colon and a SES-CD score >=7 (for patients with isolated ileal disease
SES-CD score >=4), as assessed by ileocolonoscopy and confirmed by
central independent reviewer(s) before randomisation.
2. Anti-TNF naïve patients or previously treated with infliximab who had
initially responded and who meet one of the following criteria:
a. Responded and developed secondary resistance due confirmed anti-infliximab ADA formation, which caused infliximab depletion
b. Responded and became intolerant
3. Willing to undergo up to 3 endoscopies
4. For participants of reproductive potential, a reliable means of contraception has to be used throughout trial participation.
5. Signed and dated written informed consent.

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 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
1. Ulcerative colitis or indeterminate colitis
2. Symptomatic known obstructive strictures
3. Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while in the trial
4. Ostomy or ileoanal pouch
5. Short bowel syndrome




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

Health Condition(s) or Problem(s) studied

Moderately to severely active Crohn’s disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Cyltezo
Product Code: BI 695501
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: not available
Current Sponsor code: BI 695501
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: HUMIRA (adalimumab)
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50 -

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 4

Primary end point(s): Proportion of patients in each treatment group with a clinical response (CDAI decrease of =70)

Main Objective: To compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn’s disease.

Secondary Objective: To compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases, as covered by CDAI and safety monitoring.

Secondary Outcome(s)

Secondary end point(s): Efficacy:
• Proportion of patients in each treatment group with a clinical response (CDAI decrease of =70 compared with baseline)
• Proportion of patients in each treatment group in clinical remission (CDAI <150)
Safety:
• Proportion of patients with AEs, SAEs, and AESIs (e.g., serious infections, allergic reactions, abscesses, fistula, strictures)
• Proportion of patients with infections/serious infections (seriousness of infection defined as requirement of i.v. antibiotics for treatment and/or meeting seriousness criteria to be qualified as an SAE)
• Proportion of patients who experience hypersensitivity reactions
• Proportion of patients who experience DILI
• Proportion of patients with injection-site reactions

Timepoint(s) of evaluation of this end point: Efficacy
• CDAI decrease of =70 compared with baseline at Week 24
• CDAI <150 at Week 24
Safety:
- AEs collected from time of informed consent. AEs continuing at EoT Visit must be followed to resolution of follow-up as agreed by the investigator and medical monitor. New adverse events will be collected until end of 10 week safety follow-up period.

Secondary ID(s)

1297.4

Source(s) of Monetary Support

Boehringer Ingelheim International GmbH

Ethics review

Status: Approved
Approval date: 18/01/2017
Contact:

Results

• Results available: Yes
• Date Posted: 15/05/2020
• Date Completed: 13/05/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000612-14/results