Clinical trials: Inflammatory Disease Activity
Ulcerative Colitis
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
- Trial name
- Touchstone (NCT01647516)
- Testing
- Ozanimod
- Where
- 88 sites in United States, Australia and 13 more
- Volunteers
- 199 people
- Sponsor
- Celgene
Mild to Moderate Ulcerative Colitis
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were: To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800…
- Trial name
- NCT01045018
- Testing
- Mesalamine
- Sponsor
- EMET Pharmaceuticals, LLC
Ulcerative Colitis
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis.
- Trial name
- NCT02768974
- Testing
- OPRX-106
- Where
- 7 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Protalix
Ulcerative Colitis (UC)
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis…
- Trial name
- U-Accomplish (NCT03653026)
- Testing
- Upadacitinib
- Where
- 379 sites in United States, Argentina and 42 more
- Volunteers
- 522 people
- Sponsor
- AbbVie
Crohn's Disease
Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease
his study will explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease greater than or equal to 100 from baseline and/or a CDAI < 150) over a 12-week period in…
- Trial name
- NCT00221026
- Testing
- Methoxsalen +ECP, Extracorporeal Photopheresis
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 25 people
- Sponsor
- Mallinckrodt
Crohn Disease
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's…
- Trial name
- NCT00094458
- Testing
- infliximab (IFX) infusion; azathioprine (AZA) caps
- Where
- 115 sites in United States, Austria and 13 more
- Volunteers
- 508 people
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
Polymyositis, Dermatomyositis
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients…
- Trial name
- PRESIDIO (NCT04033926)
- Testing
- KZR-616
- Where
- 14 sites in United States, Czechia and 1 more
- Volunteers
- 25 people
- Sponsor
- Kezar Life Sciences, Inc.
Ulcerative Colitis, IBD
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by…
- Trial name
- Expedition (NCT03616821)
- Testing
- Brazikumab
- Where
- 125 sites in United States, Canada and 17 more
- Volunteers
- 242 people
- Sponsor
- AstraZeneca
Crohn's Disease
Phase II Study of RR110 in Patients With Active Crohn's Disease
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.
- Trial name
- NCT00417391
- Testing
- RR110 (Tamibarotene)
- Where
- 8 sites in Japan
- Volunteers
- 24 people
- Sponsor
- R&R Inc.
Crohn Disease
Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.
- Trial name
- BLINK (NCT03241368)
- Testing
- Capsule Endoscopy
- Where
- 26 sites in United States, Austria and 1 more
- Volunteers
- 187 people
- Sponsor
- Medtronic - MITG
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease
The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of an autologous antigen-specific regulatory type 1 T lymphocyte expanded population administered via the intravenous route as an…
- Trial name
- CATS29 (NCT02327221)
- Testing
- Ovasave
- Where
- 29 sites in Austria, Belgium and 4 more
- Volunteers
- 32 people
- Sponsor
- TxCell
Ulcerative Colitis
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
- Trial name
- NCT00867438
- Testing
- Sigmoidoscopy
- Volunteers
- 133 people
- Sponsor
- Cosmo Technologies Ltd
Crohn's Disease
Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
Objectives: The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d.
- Trial name
- CD (NCT00792740)
- Testing
- ITF2357
- Where
- 10 sites in Belgium, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- Italfarmaco
Ulcerative Colitis
GB004 in Adult Subjects With Active Ulcerative Colitis
This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis.
- Trial name
- NCT03860896
- Testing
- GB004
- Where
- 3 sites in United States, Georgia and 1 more
- Volunteers
- 34 people
- Sponsor
- GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Colitis, Ulcerative
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years…
- Trial name
- ELEVATE-UCkids (NCT07470879)
- Testing
- Etrasimod
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Crohn Disease
Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.
This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in…
- Trial name
- NCT02031276
- Testing
- risankizumab IV, risankizumab SC
- Volunteers
- 121 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c.
- Trial name
- NCT01359943
- Testing
- secukinumab (AIN457)
- Where
- 39 sites in United States, Bulgaria and 6 more
- Volunteers
- 221 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.
- Trial name
- NCT01671956
- Testing
- Bertilimumab
- Where
- 6 sites in Israel
- Volunteers
- 32 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer