Brief description of trial (Data source: BASEC)
Mit dieser Studie soll herausgefunden werden ob Etrolizumab (in zwei verschiedenen Dosen) im Vergleich zu Placebo eine wirksame Behandlung ist.
Die Studie wird in eine Voruntersuchungsphase (4 Wochen), eine Induktionsphase (14 Wochen), eine Erhaltungsphase (60 Wochen) und eine Sicherheitsnachbeobachtungsphase (12 Wochen) eingeteilt.
Bei Studienaufnahme (Induktionsphase) werden Patienten in eine von 3 Kohorten aufgenommen (Zufallsprinzip durch ein Computerprogramm).
Kohorte 1: 300 Patienten werden im Verhältnis 1:2:2 für Placebo, Etrolizumab in niedriger Dosis (105 mg) oder in hoher Dosis (210 mg) zugewiesen.
Kohorte 2: 350 Patienten im Verhältnis 1:1 für Etrolizumab in niedriger Dosis oder in hoher Dosis zugewiesen.
Kohorte 3: 600 Patienten im Verhältnis 2:3:3 für Placebo, Etrolizumab in niedriger Dosis oder in hoher Dosis zugewiesen.
In Woche 14 setzen Patienten aus allen 3 Kohorten, wenn sie auf die Studienbehandlung (laut CDAI) angesprochen haben, die Studie mit dem Erhaltungsabschnitt fort.
Während des Erhaltungsabschnitts erhalten die Patienten alle 4 Wochen eine 105-mg-Dosis, die entweder Etrolizumab oder Placebo enthält.
Nach Verabreichung der letzten Dosis haben die Patienten eine 12-wöchige Sicherheitsnachbeobachtung.
Nonresponder, erhalten die Möglichkeit in die offene Verlängerungsstudie (GA29145, Teil 1) aufgenommen zu werden,
Es kann nicht garantiert werden, dass Patienten einen Nutzen aus der Teilnahme an dieser Studie haben.
Health conditions investigated(Data source: BASEC)
Mittelschwerer bis schwerer aktiver Morbus Crohn
Health conditions
(Data source: WHO)
Crohn Disease
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Etroluzimab, alle 4 Wochen subkutan injiziiert
Placebo, alle 4 Wochen subkutan injiziiert
Interventions
(Data source: WHO)
Drug: Etrolizumab;Drug: Placebo
Criteria for participation in trial
(Data source: BASEC)
In der Lage und willens, schriflich einzuwilligen
Alter von 18 bis einschl 80 Jahre
Diagnose des M. Crohn ≥ 3 Monate vor Random.
mittelschw. bis schwere aktive Erkrankung - mittels CDAI/Endoskopie
Exclusion criteria
(Data source: BASEC)
Subtotale oder totale Kolektomie
Kurzdarmsyndrom
Ileostoma od. Kolostoma
Colitis ulcerosa
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Moderately to severely active Crohn's Disease (CD) as determined by the CDAI, patient
reported outcomes and endoscopically defined disease activity in the ileum and/or
colon
- Intolerance, refractory disease, or no response to corticosteroids (CS),
immunosuppressants (IS), or anti-TNF therapy within 5 years from screening.
Participants who have not previously demonstrated inadequate response or intolerance
to one or more anti-TNF therapies are eligible to participate in the study provided
they are intolerant or refractory to CS or IS therapy
- Use of effective contraception as defined by the protocol
Exclusion Criteria:
- A history of, or current conditions affecting the digestive tract, such as ulcerative
colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess,
adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel
syndrome
- Planned surgery for CD
- Ileostomy or colostomy
- Has received non-permitted inflammatory bowel disease (IBD) therapies (including
natalizumab, vedolizumab, and efalizumab, as stated in the protocol)
- Any prior treatment with ustekinumab within 14 weeks prior to randomization
- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or
latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG]
vaccination must pass protocol-defined screening criteria)
- Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical
judgment of the investigator. Fistulas related to CD are not exclusionary
- Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell
adhesion molecule [anti-MAdCAM-1])
- Any major episode of infection requiring treatment with intravenous antibiotics =8
weeks prior to screening or oral antibiotics =4 weeks prior to screening. Treatment
with antibiotics as adjunctive therapy for CD in the absence of documented infection
is not exclusionary
- Hospitalization (other than for elective reasons) within 4 weeks prior to
randomization
-
Further information on trial
Date trial registered
Feb 27, 2015
Incorporation of the first participant
Mar 20, 2015
Recruitment status
Recruiting
Academic title
(Data source: WHO)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Induction Phase: Percentage of Participants with Clinical Remission at Week 14;Induction Phase: Percentage of Participants with Endoscopic Improvement at Week 14;Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66;Maintenance Phase: Percentage of Participants with Endoscopic Improvement at Week 66
Secundary end point
(Data source: WHO)
Induction Phase: Percentage of Participants with Clinical Remission at Week 6;Induction Phase: Percentage of Participants with SES-CD Score =4 (=2 for Ileal Participants), with No Segment Having a Subcategory Score Greater than (>)1, at Week 14;Induction Phase: Change from Baseline in Crohn's Disease-Patient-Reported Outcome Signs and Symptoms (CD-PRO/SS) Score at Week 14;Maintenance Phase: Percentage of Participants with Clinical Remission at Week 66, Among Those who Achieved Clinical Remission at Week 14;Maintenance Phase: Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 66, Among Those who Were Receiving Corticosteroids at Baseline;Maintenance Phase: Percentage of Participants with Endoscopic Improvement at Week 66 Among Participants who Achieved Endoscopic Improvement at Week 14;Maintenance Phase: Percentage of Participants with SES-CD Score =4 (=2 for Ileal Participants), with No Segment Having a Subcategory Score >1, at Week 66;Maintenance Phase: Percentage of Participants with Durable Clinical Remission;Maintenance Phase: Percentage of Participants with Corticosteroid-Free Clinical Remission for at Least 24 Weeks at Week 66, Among Those who Were Receiving Corticosteroids at Baseline;Maintenance Phase: Change from Baseline in CD-PRO/SS Score at Week 66;Overall Number of Participants who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0);Overall Number of Participants with Adverse Events Leading to Study Drug Discontinuation;Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0;Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event;Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0;Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0;Overall Number of Participants who Develop Malignancies;Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab;Observed Trough Serum Concentration (Cmin) of Etrolizuma
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern, St. Gallen
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Republic of, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. Stephan Brand
0041 71 49 4 1065
stephan.brand@kssg.ch
Contact for general information
(Data source: WHO)
Clinical Trials;Reference Study ID Number: GA29144 www.roche.com/about_roche/roche_worldwide.htm
Hoffmann-La Roche
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Contact for scientific information
(Data source: WHO)
Clinical Trials;Reference Study ID Number: GA29144 www.roche.com/about_roche/roche_worldwide.htm
Hoffmann-La Roche
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
15.03.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2015-00057
Secondary ID (Data source: WHO)
2014-003824-36
GA29144
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