Roche | Protocol GA29144
Molecule: Etrolizumab- Anti-integrin/Adhesion given SC
Study title:
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
Roche | Protocol GA29145
Open Label Extension to GA29144
Study Title:
An open-label extension and safety monitoring study of patients with moderately to severely active Crohn’s disease previously enrolled in the etrolizumab Phase III Protocol GA29144
Janssen | Protocol CNTO1959CRD3001
Molecule: Guselkumab-Antil-IL 23 (IV induction-SC maintenance) compared with placebo and active control (ustekinumab)
Study title:
A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn’s Disease.
Abbvie | Protocol M15-991, M16-006
Molecule: Risankizumab-Anti-IL 23-IV induction
Study Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn’s Disease.
Abbvie | Protocol M16-000
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 M14-431
Molecule: Upadacitinib (ABT-494)-Oral Jak inhibitor
Study Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy
Abbvie | Protocol M14-430
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.
Abbvie | Protocol M14-433
Molecule: Upadacitinib (ABT-494)-Oral Jak inhibitor
Study Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn’s Disease who have Inadequately Responded to or are Intolerant to Conventional Therapies and/or Biologic therapies.
Takeda / Protocol Cx601-0303 (Pending Approval)
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
Bristol-Myers Squibb Protocol: IM011023 (Pending Approval)
Study Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn’s Disease
Abbvie Protocol: M20-259 (Pending Approval)
Study Title: A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease Who Have Failed Anti-TNF therapy
Arena | Protocol APD334-202 (Pending Approval)
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 Health Institute Protocol: MHICC-2019-001 (Pending Approval)
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)