Clinical trials: Inflammatory Disease Activity
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.
Inflammatory Bowel Diseases, Ulcerative Colitis
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30…
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Trial name
- NCT02330653
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Stacy A. Kahn
Ulcerative Colitis
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- QUASAR (NCT04033445)
- Testing
- Guselkumab
- Where
- 392 sites in United States, Argentina and 32 more
- Volunteers
- 1,064 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.
- Trial name
- NCT02764229
- Testing
- LYC-30937-EC
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 112 people
- Sponsor
- Lycera Corp.
Ulcerative Colitis
Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.
- Trial name
- NCT03269695
- Testing
- PF-06687234
- Where
- 34 sites in United States, Australia and 8 more
- Volunteers
- 20 people
- Sponsor
- Pfizer
Crohn Disease
A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely…
- Trial name
- BERGAMOT (NCT02394028)
- Testing
- Etrolizumab
- Where
- 327 sites in United States, Argentina and 31 more
- Volunteers
- 1,035 people
- Sponsor
- Hoffmann-La Roche
Crohn's Disease
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration…
- Trial name
- NCT02611817
- Testing
- Vedolizumab SC 108 mg, Vedolizumab IV 300 mg
- Where
- 194 sites in United States, Australia and 28 more
- Volunteers
- 644 people
- Sponsor
- Takeda
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.
Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types…
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia
- Trial name
- NCT04882085
- Testing
- Zavicefta, Ceftazidime-Avibactam, Best Available Treatment
- Where
- 37 sites in China
- Volunteers
- 60 people
- Sponsor
- Pfizer
Crohn's Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis…
- Trial name
- NCT02365649
- Testing
- ABT-494
- Volunteers
- 220 people
- Sponsor
- AbbVie
Crohn's Disease, IBD
Open-label Extension Study of Brazikumab in Crohn's Disease
The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008).
- Trial name
- INTREPID OLE (NCT03961815)
- Testing
- Brazikumab Induction Dose, Brazikumab Maintenance Dose
- Where
- 15 sites in United States, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- AstraZeneca
Colitis, Ulcerative
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in…
- Trial name
- ENTERPRET (NCT03029143)
- Testing
- Vedolizumab IV
- Where
- 49 sites in United States, Canada
- Volunteers
- 278 people
- Sponsor
- Takeda
Psoriatic Arthritis
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to…
- Trial name
- SELECT - PsA 1 (NCT03104400)
- Testing
- Adalimumab, Upadacitinib
- Where
- 345 sites in United States, Argentina and 44 more
- Volunteers
- 1,705 people
- Sponsor
- AbbVie
Mild to Moderately Active Ulcerative Colitis
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a…
- Trial name
- NCT00718094
- Testing
- Polyphenon E®
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Louisville
Polymyositis, Dermatomyositis
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to…
- Trial name
- NCT04628936
- Testing
- KZR-616
- Where
- 10 sites in United States, Czechia
- Volunteers
- 18 people
- Sponsor
- Kezar Life Sciences, Inc.
Crohn Disease
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant…
- Trial name
- SEAVUE (NCT03464136)
- Testing
- Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)
- Where
- 182 sites in United States, Australia and 16 more
- Volunteers
- 386 people
- Sponsor
- Janssen Scientific Affairs, LLC
Axial Psoratic Arthritis
Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal…
- Trial name
- MAXIMISE (NCT02721966)
- Testing
- Secukinumab
- Where
- 94 sites in Belgium, Bulgaria and 16 more
- Volunteers
- 503 people
- Sponsor
- Novartis Pharmaceuticals
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
Crohn Disease
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
- Trial name
- NCT00265122
- Testing
- Ustekinumab 90 mg, Ustekinumab 4.5 mg/kg
- Where
- 57 sites in United States, Belgium and 1 more
- Volunteers
- 131 people
- Sponsor
- Centocor, Inc.
Rheumatoid Arthritis
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α…
- Trial name
- REASSURE (NCT01377012)
- Testing
- Secukinumab (AIN457)
- Where
- 142 sites in United States, Argentina and 14 more
- Volunteers
- 637 people
- Sponsor
- Novartis Pharmaceuticals