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Autoimmune Diseases clinical trials

View clinical trials related to Autoimmune Diseases.

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NCT ID: NCT06342713 Recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035

Start date: June 3, 2024
Phase: Phase 1
Study type: Interventional

This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants. Study details include: - The study duration will be up to 16 months. - The treatment duration will be up to 14 days. - Safety follow-up 30 days after last dose of study drug.

NCT ID: NCT06342700 Completed - Healthy Volunteers Clinical Trials

A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Start date: March 25, 2024
Phase: Phase 1
Study type: Interventional

This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study duration per participant is expected to be up to 36 days, including: - Screening: up to 4 weeks - Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods. - Washout: One day washout is planned after each treatment period hence providing 2 days between doses. - Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.

NCT ID: NCT06339957 Recruiting - Clinical trials for Rheumatoid Arthritis

Rheumatology Diet Study

Start date: March 1, 2024
Phase:
Study type: Observational

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.

NCT ID: NCT06318533 Recruiting - Autoimmune Diseases Clinical Trials

A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases

Start date: March 13, 2024
Phase: Early Phase 1
Study type: Interventional

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10^9 cells, 9×10^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases.

NCT ID: NCT06316791 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases

Start date: December 14, 2021
Phase: Early Phase 1
Study type: Interventional

Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.

NCT ID: NCT06316076 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases

Start date: October 30, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases

NCT ID: NCT06294236 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

Start date: April 29, 2024
Phase: Phase 1
Study type: Interventional

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

NCT ID: NCT06293365 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

NCT ID: NCT06291415 Recruiting - Hemorrhage Clinical Trials

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Start date: April 2, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

NCT ID: NCT06283316 Recruiting - Autoimmune Diseases Clinical Trials

Systemic Treatments for Alopecia Areata Registry

STA2R
Start date: January 17, 2024
Phase:
Study type: Observational [Patient Registry]

A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.