EUCTR2018-001272-37-GBActive, not recruitingPhase 1
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - DIONE - Efficacy and Safety of TD-1473 in Crohn’s Disease
Theravance Biopharma Ireland Limited0 sites160 target enrollmentStarted: October 3, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Subject is willing and able to provide written, signed informed consent at Screening Part 1 prior to start of any study-related procedures
- •2.Subject is a male or female at least 18 years of age at the time of Screening
- •3.Subject has a diagnosis of CD with involvement of at least the ileum or any portion of the colon at a minimum, diagnosed by radiology, endoscopy, and/or histology at least 3 months prior to Screening. The
- •report of a previous diagnostic exam (endoscopy, radiology, and/or pathology) must be reviewed by the investigator and included in the source documents.
- •4.Subjects must have up-to-date colorectal cancer screening as per locally adopted guidelines (e.g., if subject has had = 8 years of disease involving >30% of the colon, surveillance biopsies or chromoendoscopy
- •should be performed if either is indicated as per locally adopted guidelines but has not been performed within the 12 months prior to Screening). If indicated, the surveillance biopsies (if = 10) and chromoendoscopy need to be performed during Screening Stage 2 ileocolonoscopy after recording of a full ileocolonoscopy has been completed to avoid dye or biopsy related bleeding artifact on the recorded images.
- •5.Subject has CDAI score = 220 and = 450
- •6.Subject has a SES-CD score of = 3 with ulceration (corresponding to a score of =1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES CD, as assessed by central reading, during
- •a.Up to approximately 10% of the study population will have SES-CD score of between 3 and 5, inclusive, with the presence of ulceration in any 1 of the 5 ileocolonic segments, all other subjects (approximately
- •90% of the study population) will require an SES-CD score of = 6 (= 4 if isolated ileal disease) with ulceration (corresponding to a score of = 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface
- •subscore of the SES-CD
- •7.Subject is corticosteroid-dependent or had intolerance or inadequate response to any of the following: aminosalicylates, corticosteroids, immunomodulators (azathioprine, 6 mercaptopurine, or methotrexate),
- •or biologics (anti-TNF anti-IL-12/IL-23 therapy, or anti-integrin)
- •NOTE: For subjects in Portugal, subject must have had intolerance or inadequate response to biologics
- •8.If subject is currently receiving an oral corticosteroid, subject is eligible if:
- •a.the subject has been on corticosteroid for a minimum of 4 weeks prior to Day 1 AND
- •b.the dose is equivalent to or less than prednisone 25 mg/day or budesonide 9 mg/day or beclomethasone at 5 mg/day AND
- •c.the dose is stable for at least 2 weeks prior to Screening Stage 2 AND
- •d.the subject is willing to continue on the same dose as warranted until Week 8
- •9.if subject is currently receiving oral aminosalicylate (including, but not limited to sulfasalazine or mesalamine), the subject is eligible provided the subject has been on a stable dose for = 4 weeks prior to Day 1 and is willing to stay on the same dose as warranted until Week 12.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •Exclusion Criteria Pertinent to GI:
- •1.Subject with a confirmed or suspected diagnosis or history of primary sclerosing cholangitis (PSC)
- •2.Subject has had extensive colonic resection (i.e. more than half of colon), subtotal or total colectomy, intestinal resection within 6 months of Screening, > 2 small bowel resections or carries a diagnosis of short
- •bowel syndrome or currently has an ostomy
- •3.Subject has a history of unresected colonic mucosal dysplasia or history of resected high-grade colonic dysplasia within 3 years prior to Screening. Subjects will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia or because of adenomas that have been completely resected
- •Exclusion Criteria Pertinent to Medications:
- •1.Medications of exclusion (Refer to Section 6.4.29 and Appendix 11 for prohibited medications) below must be discontinued within the timeframe specified (if applicable)
- •azathioprine, 6-mercaptopurine, or methotrexate taken within the 14 days prior to Day 1
- •anti-TNFs (e.g., adalimumab, infliximab, golimumab, etanercept, certolizumab, or biosimilars) taken within the 60 days or 5 half-lives, whichever is longer, prior to Day 1
- •intravenous corticosteroids within the 14 days prior to Day 1
- •rectal mesalamine or corticosteroid (i.e. enemas or suppositories) taken within the 14 days prior to Day 1
- •prior exposure to vedolizumab, ustekinumab, mycophenolic acid, tacrolimus, sirolimus, or cyclosporine taken within 60 days or 5 half-lives, whichever is longer prior to Day 1
- •any prior exposure to natalizumab, rituximab, efalizumab, fingolimod, cyclophosphamide, or thalidomide
- •NSAIDs taken on a regular (more than 3 times per week, on average) basis (regular use of aspirin = 325 mg per day for cardiovascular protection is allowed).
- •anakinra or any other immune-modifying biologic agent taken within 90 days prior to Day 1
- •A JAK inhibitor (e.g. tofacitinib) within 60 days prior to Day 1
- •2.Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy. This does not include subjects with prior exposure to another JAK inhibitor that was stopped
- •for any other reason (e.g. loss/lack of insurance coverage or end of study)
- •3.Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently
- •participating in another trial of an investigational drug (or medical device)
- •4.Subject has had inadequate response (i.e. either primary or secondary non-response) to = 3 biologic agents of 3 different mechanisms of action (i.e. anti TNF, anti-integrin, and anti-IL12/23)
- •Exclusion Criteria Pertinent to Infections:
- •1.Subject is positive for:
- •a.HBV surface antigen
- •b.HBV core antibody (unless subject has positive hepatitis B surface antibody and undetectable serum hepatitis B DNA)
- •c.HCV antibody unless: a) there is evidence of undetectable viral load measured twice 6 months apart after completion of treatment regimen and b) viral load during Screening is undetectable
- •d.hepatitis E IgM antibody
- •e.HIV antibody
- •2.The subject has or may have untreated active or latent TB as evidenced by any of the following:
- •a.Two indeterminate or two positive QuantiFERON®TB Gold result within 90 days prior to screening or during the Screening Period, without having completed an adequate treatment for late
Investigators
Similar Trials
Active, not recruiting
Phase 1
A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseEUCTR2018-001272-37-GRTheravance Biopharma US, Inc.160
Active, not recruiting
Phase 1
A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseEUCTR2018-001272-37-ATTheravance Biopharma Ireland Limited160
Active, not recruiting
Phase 1
A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseEUCTR2018-001272-37-BGTheravance Biopharma Ireland Limited160
Active, not recruiting
Phase 1
A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseModerately-to-Severely Active Crohn’s Disease (CD)MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856EUCTR2018-001272-37-FRTheravance Biopharma Ireland Limited160
Active, not recruiting
Phase 1
A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's DiseaseEUCTR2018-001272-37-ROTheravance Biopharma UC Inc.160