Arena | Protocol APD334-202 - Currently recruiting
Molecule: Etrasimod (orally administered, selective, synthetic sphingosine 1-phosphate (S1P) receptor 1, 4, 5 modulator)
Study Title:
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease.
Sponsor Montreal Heart Institute Protocol: MHICC-2019-001 - Currently recruiting
Molecule : Terbinafine & Itraconazcole
Study Title:
Evaluation of the response of itraconazole and terbinafine therapy in subjects with Crohn’s disease not responding adequately to current therapy (CD-IT)
Abbvie | Protocol M16-000 - Close to recruitment
Molecule: Risakizumab-52 week maintenance & Open Label Extension to M15-991 or M16-006. SC injections +/- IV rescue
Study Title:
A Multicenter Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn’s Disease Who Responded to Induction Treatment in M16-006 or M15-991.
Abbvie | Protocol M14-430 - Close to recruitment
Molecule: LTE study-Upadacitinib (ABT-494)-Oral Jak inhibitor
Study Title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled Maintenance and Long Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn’s Disease who completed the M14-431 or M14-433 Studies.
Takeda / Protocol Cx601-0303 - Close to recruitment
Study Title:
A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn’s Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks
Janssen | Protocol CNTO1959CRD3005 (FUZION) - Pending approbation
Molecule: Guselkumab for Fistulizing Crohn's Disease (Anti-Il23p19)
Study title:
A phase 3, randomized, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of guselkumab in participants with fistulizing, perianal Crohn’s Disease
Janssen | Protocol CNTO1959CRD3007 (PROGRESS) - Pending approbation
Molecule: Guselkumab in Post-operative CD (Anti-Il23p19)
Study title:
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants with Crohn’s Disease After Surgical Resection
Janssen | Protocol 78934804CRD2001 (DUET-CD) - Pending approbation
Molecule: Combination Therapy with Guselkumab (Anti-Il23 p19) and Golimumab (Anti-TNF)
Study title:
A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease
AstraZeneca | Protocol D5271C00001 (INTREPID-Lead in) - Pending approbation
Molecule: Brazikumab (Anti-IL23)
Study title:
A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease
JAMP | Protocol JAMP-AVT02-001 (EASE-PAIN Trial) - Pending approbation
Molecule: Simlandi (Adalimumab Biosimilar)
Study title:
The evaluation of injection site pain and adherence in patients switching from a low to high concentration Adalimumab (AVT-02) across multiple indications.
Beth Israel Medical Center & Alimentiv | Protocol RCT01437 (OPTIMIZE Trial) - Pending approbation
Molecule: N/A
Study title:
Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn’s disease: The OPTIMIZE Trial