Brief description of trial (Data source: BASEC)
Es handelt sich hier um eine randomisierte, doppelblinde, placebokontrollierte Studie.
Randomisiert bedeutet, dass die Studienbehandlung per Zufall gewählt wird – etwa wie beim Werfen einer Münze. Im ersten Teil der Studie (die ersten 11 Wochen) ist die Wahrscheinlichkeit, Filgotinib 200 mg zu erhalten, 1 von 3 (ungefähr 33 %), die Wahrscheinlichkeit, Filgotinib 100 mg zu erhalten, 1 von 3 (ungefähr 33 %), die Wahrscheinlichkeit, Placebo zu erhalten, 1 von 3 (ungefähr 33 %).
Basierend auf den Untersuchungsergebnissen in Woche 10 werden Patienten entweder für den zweiten Teil der Studie erneut randomisiert oder sie erhalten die Möglichkeit, an einer separaten langfristigen Verlängerungsstudie teilzunehmen, wenn sie dafür geeignet sind.
Im zweiten Teil der Studie werden Patienten erneut randomisiert. Die Wahrscheinlichkeit, die bisherige Behandlung fortzusetzen, ist 2 von 3 (etwa 66 %), und die Wahrscheinlichkeit, Placebo ("Zuckerpille") zu erhalten, ist 1 von 3 (etwa 33 %). Patienten, die in den ersten 11 Wochen Placebo erhalten haben und deren Symptome oder Ergebnisse einer Darmspiegelung besser sind, erhalten weiterhin Placebo.
Doppelblind bedeutet, dass weder der Patient noch der Prüfarzt wissen werden, welches Studienmedikament der Patient nimmt. Placebokontrolliert bedeutet, dass Patienten eventuell eine Tablette einnehmen, die keinen Wirkstoff enthält, aber wie Filgotinib aussieht.
Die Teilnahme an dieser Studie wird etwa 58 Wochen dauern, der Voruntersuchungstermin oder der Besuchstermin nach Behandlungsende (30 Tage nach der letzten Dosis) nicht eingeschlossen.
In dieser Zeit müssen Patienten das Prüfzentrum mindestens 13-mal aufsuchen. Frauen im gebärfähigen Alter müssen das Prüfzentrum mindestens 19-mal aufsuchen.
Health conditions investigated(Data source: BASEC)
Morbus Crohn
Health conditions
(Data source: WHO)
Crohn's Disease
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Im ersten Teil der Studie:
• Behandlung 1: Filgotinib 200 mg täglich
• Behandlung 2: Filgotinib 100 mg täglich
• Behandlung 3: Placebo täglich
Im zweiten Teil der Studie:
• Patienten die in den ersten 11 Wochen in Behandlung 1 waren, setzen entweder Behandlung 1 fort oder werden Behandlung 3 zugewiesen
• Patienten die in den ersten 11 Wochen in Behandlung 2 waren, setzen entweder Behandlung 2 fort oder werden Behandlung 3 zugewiesen
• Patienten die in den ersten 11 Wochen in Behandlung 3 waren, setzen Behandlung 3 fort
Interventions
(Data source: WHO)
Drug: Filgotinib;Drug: Placebo to match filgotinib
Criteria for participation in trial
(Data source: BASEC)
Erwachsene Patienten mit mässig bis stark aktivem Morbus Crohn
Männliche Probanden und Frauen im gebärfähigen Alter, die sich im heterosexuellen
Geschlechtsverkehr engagieren, müssen einverstanden sein, die Verhütungsmethoden, wie im Protokoll beschrieben, zu verwenden.
Exclusion criteria
(Data source: BASEC)
Colitis ulcerosa, unbestimmte Colitis, ischämische Colitis, fulminante Colitis, toxisches Megakolon
Inclusion/Exclusion Criteria
(Data source: WHO)
Key Inclusion Criteria:
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
the date of the screening visit
- Documented diagnosis of CD with a minimum disease duration of 3 months with
involvement of the ileum and/or colon at a minimum, as determined by histopathology
and endoscopic assessment
- Moderately to severely active CD
- Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response,
loss of response to, or intolerance to at least 1 of the following agents (depending
on current country treatment recommendations/guidelines): corticosteroids and
immunomodulators
- Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical
response, loss of response to, or intolerance to at least 1 of the following agents
(depending on current country treatment recommendations/guidelines) or discontinuation
of use of at least one of the following agents for reasons other than inadequate
clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa)
antagonists, vedolizumab, and ustekinumab
- Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical
response, loss of response to, or intolerance to at least 1 of the following agents
(depending on current country treatment recommendations/guidelines): TNFa antagonists,
vedolizumab, and ustekinumab
Key Exclusion Criteria:
- Current complications of CD such as symptomatic strictures, severe rectal/anal
stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
colitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any prohibited concomitant medications as described in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
-
Further information on trial
Date trial registered
Sep 22, 2016
Incorporation of the first participant
Oct 31, 2016
Recruitment status
Completed
Academic title
(Data source: WHO)
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects 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 Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10;Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10;Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58;Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58
Secundary end point
(Data source: WHO)
Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10;Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10;Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845;Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58;Maintenance Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 58;Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI;Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by CDAI at Week 58;Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2;Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58;Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
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
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Frank Seibold
+41 31 302 32 34
bern@magendarmsuisse.ch
Contact for general information
(Data source: WHO)
Gilead Study Director
Gilead Sciences
Contact for scientific information
(Data source: WHO)
Gilead Study Director
Gilead Sciences
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
02.05.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-02164
Secondary ID (Data source: WHO)
2016-001367-36
GS-US-419-3895
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