Crohn syndrome regional enteritis
Conditions
Interventions
Treatment Regimen (Cohorts A and B Induction Studies)
Subjects who meet protocol eligibility criteria will be assigned to the
respective Cohort and subsequently randomized in a blinded fashion in a
Sponsors
Gilead Sciences
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For a complete list of study inclusion and exclusion criteria, please refer to Section 4. , Main Eligibility Criteria (Cohorts A & B): All subjects must meet all of the following criteria to be eligible for participation in either the Cohort A or B Induction Study. • 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, documented by the following: a) Medical record documentation of, or an ileocolonoscopy (full colonoscopy with the intubation of terminal ileum) report dated >= 3 months before enrollment, which shows features consistent with CD, determined by the procedure performing physician, AND b) Medical record documentation of, or a histopathology report showing features consistent with CD, determined by the pathologist. • Moderately to severely active CD determined by CDAI 220 to 450 (inclusive), AND PRO2 (abdominal pain score >= 2 [on a scale of 0 to 3] OR stool frequency >= 4), AND centrally read SES CD score >= 6 (or >= 4 if disease is limited to the ileum and/or right colon) • May be receiving the following drugs (subjects on these therapies must be willing to remain on stable doses for the noted time): a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must remain stable for the first 10 weeks after randomization b) Azathioprine or 6-MP or MTX provided the dose prescribed has been stable for 4 weeks prior to randomization; dose must remain stable for the first 10 weeks after randomization c) Oral corticosteroid therapy (prednisone prescribed at a stable dose <= 30 mg/day or budesonide prescribed at a stable dose of <= 9 mg/day) provided the dose prescribed has been stable for 2 weeks prior to randomization; dose must remain stable for the first 14 weeks after randomization d) Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) provided the dose prescribed has been stable for 2 weeks prior to randomization. Dose must remain stable for the first 10 weeks after randomization. Subjects who are on cyclic therapy must continue their standard low-dose regimen without change for the first 10 weeks after randomization. • Must not have the current following complications of CD: a) Symptomatic strictures, OR b) Severe (impassable) rectal/anal stenosis, OR c) Fistulae other than perianal fistulae, OR d) Short bowel syndrome, OR e) Any other manifestation that might require surgery, OR f) Any other complications which could preclude the use of the CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with filgotinib • Must not have ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon • Must not have active tuberculosis (TB) or history of latent TB that has not been treated (see inclusion criterion 7 for further information) • Must not use any prohibited concomitant medications as described in Section 5.4.2 Cohort A (Biologic-Naïve and Biologic-Experienced) Induction Study Main Eligibility Criteria, Cohort A ONLY Subjects must meet all of the additional criteri
Exclusion criteria
Exclusion criteria: See above Main Eligibility Criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy will be assessed by CDAI and SES-CD (co primary): • Clinical remission by CDAI is defined CDAI = 50% from baseline In the EU, primary efficacy will be assessed by PRO2 and SES-CD (co-primary): • Clinical remission by PRO2 is defined as abdominal pain score = 50% from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| See objectives of the study | — |
Countries
Netherlands
Outcome results
None listed