GI Clinical Trials

M15-722: Ulcerative Colitis: Ravagalimab (ABBV-323) in Subjects with Moderately to Severely Active UC Who Failed Prior Therapy

• Disease: Moderate/Severe Ulcerative Colitis
• Study Drug: Ravagalimab
• Phase: IIa
• Participation: Open-label induction and maintenance study, up to 104 weeks long

CARMEN 305: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305)

• Sponsor: Shire Human Genetic Therapies, Inc.
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Ontamalimab
• Phase: III

CARMEN 307: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307)

• Sponsor: Shire Human Genetic Therapies, Inc.
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Ontamalimab
• Phase: III

CARMEN 304: A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA)

• Sponsor: Shire Human Genetic Therapies, Inc.
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Ontamalimab
• Phase: III

M14-675: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

• Sponsor: AbbVie
• Disease: Moderate/Severe Ulcerative Colitis
• Study Drug: Upadacitinib
• Phase: III

M14-675: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

• Sponsor: AbbVie
• Disease: Moderate/Severe Ulcerative Colitis
• Study Drug: Upadacitinib
• Phase: III

M14-234: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

• Sponsor: AbbVie
• Disease: Moderate/Severe Ulcerative Colitis
• Study Drug: Upadacitinib
• Phase: II/III

M14-533: A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis

• Sponsor: AbbVie
• Disease: Moderate/Severe Ulcerative Colitis
• Study Drug: Upadacitinib
• Phase: III

M15-991: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

• Sponsor: AbbVie
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Risankizumab
• Phase: III

M16-006: 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

• Sponsor: AbbVie
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Risankizumab
• Phase: III

M16-000: 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; or Completed M15-989

• Sponsor: AbbVie
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Risankizumab
• Phase: III

Lucent 1 (AMAN): A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis

• Sponsor: Eli Lilly
• Disease: Moderate/Severe Ulcerative Colitis
• Study Drug: Mirikizumab
• Phase: III

CT-P13 3.8: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease

• Sponsor: Celltrion PPD
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Infliximab
• Phase: III

DINE-CD: Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients with Crohn’s Disease

• Sponsor: Perelman School of Medicine, University of Pennsylvania
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: Study Diet

Techlab: Evaluating the Clinical Performance of Fecal Biomarkers in Elderly Inflammatory Bowel Disease Patients

• Sponsor: Initiated by Dr. Sasha Taleban
• Disease: Moderate/Severe ulcerative colitis and Crohn’s Disease

Secure: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease

• Sponsor: UCB Biosciences Inc.
• Disease: Crohn’s Disease
• Study Drug: Cimzia

PASS: Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease.

• Sponsor: Takeda
• Disease: Ulcerative colitis and Crohn’s Disease
• Study Drug: Vedolizumab

Legacy: A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

• Sponsor: AbbVie
• Disease: Moderate/Severe Crohn’s Disease
• Study Drug: HUMIRA® (adalimumab)