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NCT ID: NCT05014672 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness

TRANSFORM
Start date: February 14, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).

NCT ID: NCT05013905 Active, not recruiting - Crohn Disease Clinical Trials

A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

APOLLO-CD
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.

NCT ID: NCT05009875 Active, not recruiting - Osteopenia Clinical Trials

Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

The aim of the trial is to determine if the SYNBIOTIC (prebiotic and probiotic), provided twice daily (capsule) will help support skeletal health in otherwise healthy postmenopausal women in the early years postmenopause (1-6 years post last menstruation) over a 12-month period.

NCT ID: NCT05008224 Active, not recruiting - Clinical trials for Classical Hodgkin Lymphoma

Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)

KEYNOTE-C11
Start date: October 7, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.

NCT ID: NCT05005975 Active, not recruiting - XLP Clinical Trials

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Start date: August 10, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the long-term safety and tolerability of oral dersimelagon.

NCT ID: NCT05003804 Active, not recruiting - Atopic Dermatitis Clinical Trials

Allergic Disease Onset Prevention Study

adored
Start date: September 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2, randomized, double-blind, multi-center study to evaluate the safety, tolerability, and preliminary clinical efficacy of STMC-103H in neonates and infants at risk for developing allergic disease (Type 1 hypersensitivity). Subjects will be enrolled in a three-part sequential approach. Participants in the safety-run portion of the study (Part A1: 1 year to <6 years of age and A2: 1 month to <12 months of age) will receive 28 days of treatment with STMC-103H or placebo, followed by 28 days of follow-up. A Data and Safety Monitoring Committee (DSMC) will review safety data after all patients in each part complete 28 days of therapy prior to enrolling the next part. After A2, Part B will enroll 224 patients for 336 days of treatment with STMC-103H or placebo, followed by 336 days of follow-up. Stool, blood, and optional samples will be collected in Parts A2 and part B. Primary safety endpoints are frequency, type and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), as well as findings on physical exams, vitals, and safety laboratories. The primary efficacy endpoint is incidence of physician-diagnosed atopic dermatitis at day 336.

NCT ID: NCT05002569 Active, not recruiting - Melanoma Clinical Trials

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

RELATIVITY-098
Start date: October 19, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

NCT ID: NCT04997954 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

EMERALD TRIAL Open Label Extension Study

EMERALD-OLE
Start date: May 17, 2021
Phase: Phase 4
Study type: Interventional

EMERALD OLE trial is an open-label extension of the EMERALD trial. Long term tolerability and safety of the MediCabilis CBD oil has not been extensively studied. EMERALD OLE aims to establish data on the prolonged used of the study drug product. All participants who completed the EMERALD trial will be offered to enter EMERALD OLE. Participants will be taking the active drug MediCabilis CBD oil for 6 months.

NCT ID: NCT04996797 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

ARTEMIS-UC
Start date: July 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Ulcerative Colitis. The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active ulcerative colitis who are companion diagnostic positive. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for another 38 weeks.

NCT ID: NCT04995523 Active, not recruiting - Clinical trials for Non-Small-Cell Lung Carcinoma

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

ARTEMIDE-01
Start date: September 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.