Abbvie – M14-033 Serene, Protocol M14-033

Double-blind, randomized, multicenter study of higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis. (Abbvie)

Abbvie – M14-234  U-Achieve Protocol M14-234

A phase IIB/III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ABT494 during induction and maintenance in patients with moderate to severe active ulcerative colitis. (Abbvie) 

Abivax – Protocol ABX464-101

A phase IIa study to evaluate the efficacy and safety of ABX464 50 mg once daily versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNF alpha, vedolizumab and/or corticosteroids. (Abivax)

Alicaforsen protocol ACH UCP-301

A phase III randomised, double-blind, placebo-controlled trial of the safety and efficacy of topical Alicaforsen enema (Human ICAM-1 antisense phosphorothioate oligonucleotide) in subjects with active, chronic, antibiotic refractory primary idiopathic pouchitis. (Atlantic Pharmaceuticals)

Earnest, Protocol Vedolizumab-4004

A phase IV, randomized, double-blinded placebo-controlled study to evaluate the efficacy and safety of Entyvio (vedolizumab IV) in the treatment of chronic pouchitis. (Takeda)

Gilead/Galapagos Protocol GS-US-418-3898

A phase III, double blind, multi dose, placebo controlled, study to evaluate the efficacy and safety of filgotinib in the induction and maintenance of remission in subjects with moderate to severe ulcerative colitis. (Gilead Sciences)

Legacy, Protocol P11-282

A long-term non-interventional registry to assess safety and effectiveness of Humira® (adalimumab) in patients with moderately to severely active ulcerative colitis. (AbbVie)

Pfizer Tuscany, Protocol B7541002

A phase 2A, multicenter, single arm, open-label study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06480605 in subjects with moderate to severe ulcerative colitis. (Pfizer)

Protagonist, Protocol PTG-100-02

A phase 2B, randomized, double blind, placebo controlled, parallel adaptive 2-stage, multicenter study to evaluate the efficacy and safety of oral PTG-100 induction in subjects with moderate to severe ulcerative colitis.

Receptos True North study, Protocol RPC01-3101

A phase III, multicenter, randomized, double-blind, placebo-controlled trial of oral RPC1063 as induction and maintenance for moderate to severe ulcerative colitis. (Receptos)

Receptos True North study, Protocol RPC01-3102

Extension of the phase III trial (protocol RPC01-310). Treatment with oral RPC1063 moderate to severe ulcerative colitis. (Receptos)

Roche-Genentech-Hickory, Protocol GA28950

A phase III, double-blind, placebo-controlled, multicenter study of the efficacy and safety of etrolizumab during induction and maintenance in patients with moderate to severe active ulcerative colitis who are refractory to or intolerant of anti-TNF. (Roche-Genentech)

Roche-Genentech-Cottonwood, Protocol GA28951

An open-label extension and safety monitoring study of moderate to severe ulcerative colitis patients previously enrolled in etrolizumab phase III studies. (Roche-Genentech)

Tacrolimus suppositories, Protocol ID ZonMW 80-83600-98-10006

Tacrolimus suppositories versus beclomethasone suppositories for the treatment of proctitis refractory to local 5-ASA. Investigator initiated study

Love UC

An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in Ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) (Takeda) Investigator initiated study

Food influence on the Intestinal microbioTa (FIT) trial

Food intervention study to modulate intestinal microbiota and prevent disease relapse in patients with ulcerative colitis in remission. Investigator initiated study

HELP-AID

Home basEd feacal calProtectin measurements predicting Adalimumab Induction Destiny. Investigator initiated study, Bird

Pacific

Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Indution in patients with Crohn's disease and ulcerative colitis. Investigator initiated study, Bird

Connect IBD

Post-Marketing Observational Cohort study of patients with inflammatory bowel disease (IBD) treated with Inflectra. (Pfizer)

 

 

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