Clinical trials: IBD-Inflammatory Bowel Disease
Ulcerative Colitis
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- TOPAZ-UC (NCT07186101)
- Testing
- LY4268989, Mirikizumab
- Where
- 147 sites in United States, Austria and 15 more
- Volunteers
- 252 people
- Sponsor
- Eli Lilly and Company
Crohn's Disease
An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world.
- Trial name
- NCT06023030
- Where
- 104 sites in Japan
- Volunteers
- 240 people
- Sponsor
- AbbVie
Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative…
- Trial name
- NCT04504383
- Testing
- PN-943
- Where
- 122 sites in United States, Austria and 11 more
- Volunteers
- 169 people
- Sponsor
- Protagonist Therapeutics, Inc.
Iron Deficiency Anaemia
Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With The Intravenous Iron (Monofer®)
The objective is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient populations when Monofer® is used…
- Trial name
- NCT02546154
- Testing
- 10% Iron Isomaltoside 1000
- Where
- United Kingdom
- Volunteers
- 359 people
- Sponsor
- Pharmacosmos UK Ltd
Crohn´s Disease
Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only. This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs.
- Trial name
- TRUST-2 (NCT01279577)
- Testing
- Low dose TSO, Medium dose TSO, High dose TSO
- Where
- Germany
- Volunteers
- 254 people
- Sponsor
- Dr. Falk Pharma GmbH
Crohn's Disease
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
- Trial name
- NCT02065570
- Testing
- Adalimumab
- Where
- 143 sites in United States, Austria and 18 more
- Volunteers
- 514 people
- Sponsor
- AbbVie
Inflammatory Bowel Disease (IBD), Anemia
Study of DISC-0974-201 in Participants With IBD and Anemia
This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in participants with IBD and anemia of inflammation.
- Conditions
- Inflammatory Bowel Disease (IBD), Anemia, Inflammatory Bowel Disease (IBD); Anemia
- Trial name
- NCT07368972
- Testing
- DISC-0974
- Where
- 15 sites in United States
- Volunteers
- 21 people
- Sponsor
- Disc Medicine, Inc
Ulcerative Colitis, Crohn's Disease
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
- Trial name
- FENNEL (NCT03478956)
- Testing
- Etrolizumab
- Where
- 5 sites in Belgium, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease
Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464, administered once daily (QD), in inducing clinical remission and endoscopic response in patients with moderate to severe…
- Trial name
- NCT03905109
- Testing
- ABX464
- Where
- Belgium
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
- Trial name
- OCTAVE (NCT01470612)
- Testing
- CP-690,550
- Where
- 252 sites in United States, Australia and 29 more
- Volunteers
- 944 people
- Sponsor
- Pfizer
Crohn's Disease
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
- Trial name
- NCT03105128
- Testing
- risankizumab IV, risankizumab SC
- Where
- 475 sites in United States, Argentina and 42 more
- Volunteers
- 931 people
- Sponsor
- AbbVie
Ulcerative Colitis
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
- Trial name
- NCT00326209
- Testing
- Encapsulated Mesalamine Granules (eMG)
- Where
- 61 sites in United States
- Volunteers
- 393 people
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis
- Trial name
- NCT00449722
- Testing
- mesalazine
- Where
- Germany
- Volunteers
- 380 people
- Sponsor
- Dr. Falk Pharma GmbH
Crohn's Disease
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
- Trial name
- DUET-CD (NCT05242471)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 456 sites in United States, Australia and 34 more
- Volunteers
- 703 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation
The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation…
- Trial name
- NCT03850509
- Testing
- OPS-2071
- Where
- 31 sites in United States, Poland
- Volunteers
- 3 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Ulcerative Colitis (UC)
Efficacy & Safety of TD-1473 in Ulcerative Colitis
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
- Trial name
- RHEA (NCT03758443)
- Testing
- TD-1473 Dose A, TD-1473 Dose B, TD-1473 Dose C
- Where
- 188 sites in United States, Australia and 20 more
- Volunteers
- 239 people
- Sponsor
- Theravance Biopharma
Crohn Disease
Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
- Trial name
- NCT00206713
- Testing
- Sargramostim (Leukine)
- Where
- 7 sites in United States
- Volunteers
- 264 people
- Sponsor
- Genzyme, a Sanofi Company
Crohns Disease
Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients
The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC) of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard 6MP (100 mg Purinethol) in 12 patients with…
- Trial name
- NCT00774982
- Testing
- Delayed Release 6 mercaptopurine, 6 Mercaptopurine
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Teva GTC
Ulcerative Colitis
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
- Trial name
- SMART (NCT02155335)
- Testing
- Prefilled Syringe delivery of Golimumab, Smartject Device delivery of Golimumab
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease
Vagus Nerve Stimulation in Crohn's Disease
This is an open label interventional study using an implantable vagus nerve stimulation device in patients with Crohn's disease who have active disease despite treatment with a tumor necrosis factor (TNF) antagonist drug.
- Trial name
- NCT02311660
- Testing
- Vagus Nerve Stimulation Device
- Where
- 4 sites in Croatia, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- SetPoint Medical Corporation
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