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NCT ID: NCT05514548 Active, not recruiting - Clinical trials for Diabetic Kidney Disease

Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

Start date: October 19, 2022
Phase: Phase 2
Study type: Interventional

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with a diagnosis of Diabetic Kidney Disease due to either Type 1 diabetes mellitus or Type 2 diabetes mellitus

NCT ID: NCT05511363 Recruiting - Clinical trials for Psychosis Associated With Alzheimer's Disease

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

ADEPT-1
Start date: August 23, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

NCT ID: NCT05507216 Recruiting - Ulcerative Colitis Clinical Trials

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

Start date: December 21, 2022
Phase: Phase 3
Study type: Interventional

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 who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].

NCT ID: NCT05499130 Recruiting - Crohn Disease Clinical Trials

A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

RELIEVE UCCD
Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: - To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures - To evaluate the safety and tolerability of the 2 different dose regimens - To evaluate the immunogenicity of the 2 different dose regimens The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

NCT ID: NCT05462717 Active, not recruiting - Clinical trials for Advanced Solid Tumor

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Start date: September 19, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

NCT ID: NCT05462522 Recruiting - Systemic Sclerosis Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis

Start date: January 16, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.

NCT ID: NCT05460832 Completed - Clinical trials for Rheumatoid Arthritis

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage. The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate. Approximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug). The maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks. Participants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.

NCT ID: NCT05450692 Active, not recruiting - Clinical trials for Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

LATIFY
Start date: September 15, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

NCT ID: NCT05438862 Recruiting - Clinical trials for Aortic Valve Regurgitation

Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation

ELEANOR
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.

NCT ID: NCT05437263 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

VALOR
Start date: October 31, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.