Clinical trials: Autoimmune
Autoimmune Pulmonary Alveolar Proteinosis
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim (MOL) or placebo (PBO) for 48 weeks.
- Trial name
- IMPALA-2 (NCT04544293)
- Testing
- Molgramostim, Molgramostim Open-label
- Where
- 54 sites in United States, Australia and 16 more
- Volunteers
- 164 people
- Sponsor
- Savara Inc.
Warm Autoimmune Hemolytic Anemia (wAIHA)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
- Trial name
- NCT04691570
- Testing
- ANX005
- Where
- 4 sites in United States, Australia and 2 more
- Volunteers
- 7 people
- Sponsor
- Annexon, Inc.
Sjögren Syndrome
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
- Trial name
- TWINSS (NCT03905525)
- Testing
- CFZ533
- Where
- 71 sites in United States, Argentina and 21 more
- Volunteers
- 273 people
- Sponsor
- Novartis Pharmaceuticals
Immunoglobulin A Nephropathy, Glomerular Disease
Safety and Efficacy Study of VIS649 for IgA Nephropathy
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy, Glomerular Disease, IgAN
- Trial name
- NCT04287985
- Testing
- Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
- Where
- 93 sites in United States, Australia and 13 more
- Volunteers
- 155 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline
Autoimmune Hepatitis
A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)
This was a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis received zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period…
- Trial name
- NCT05569759
- Testing
- zetomipzomib, zetomipzomib in open-label extension
- Where
- 24 sites in United States
- Volunteers
- 24 people
- Sponsor
- Kezar Life Sciences, Inc.
Rheumatoid Arthritis, Arthritis
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases
- Trial name
- RESOLUTION-1 (NCT05516758)
- Testing
- Peresolimab
- Where
- 131 sites in United States, Argentina and 9 more
- Volunteers
- 491 people
- Sponsor
- Eli Lilly and Company
Warm Autoimmune Hemolytic Anemia (wAIHA)
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
- Trial name
- PATHWAY (NCT05073458)
- Testing
- parsaclisinib
- Where
- 56 sites in United States, Austria and 11 more
- Volunteers
- 13 people
- Sponsor
- Incyte Corporation
Cold Agglutinin Disease
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin…
- Trial name
- NCT05096403
- Testing
- Pegcetacoplan
- Where
- 44 sites in United States, Austria and 12 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
Immune Thrombocytopenia (ITP), Cold Agglutinin Disease (CAD)
Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders
The main purpose of this study was to evaluate the efficacy and safety of iptacopan in participants with autoimmune benign hematological disorders such as primary immune thrombocytopenia and primary cold agglutinin disease.
- Trial name
- NCT05086744
- Testing
- Iptacopan
- Where
- 8 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Cold Agglutinin Disease
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number…
- Trial name
- NCT05132127
- Testing
- sutimlimab
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active…
- Trial name
- Synergy (NCT04835441)
- Testing
- ALPN-101
- Where
- 46 sites in United States, France and 5 more
- Volunteers
- 76 people
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
Autoimmune Hemolytic Anemia
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that…
- Trial name
- NCT03538041
- Testing
- Parsaclisib
- Where
- 12 sites in United States, Austria and 2 more
- Volunteers
- 25 people
- Sponsor
- Incyte Corporation
Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.
- Trial name
- NCT04875975
- Testing
- Rozanolixizumab
- Where
- 27 sites in United States, Australia and 7 more
- Volunteers
- 12 people
- Sponsor
- UCB Biopharma SRL
Diabetes Mellitus
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its…
- Trial name
- NCT01073566
- Testing
- Finesse, Pen/Syringe (Usual injection device)
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- Calibra Medical, Inc.
Systemic Lupus Erythematosus
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.
- Trial name
- NCT05123586
- Testing
- LY3361237
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 85 people
- Sponsor
- Eli Lilly and Company
Rheumatoid Arthritis
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD)…
- Trial name
- CAPRA-2 (NCT00650078)
- Testing
- MR prednisone
- Where
- 52 sites in United States, Canada and 4 more
- Volunteers
- 350 people
- Sponsor
- Amgen
Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
- Trial name
- NCT03226678
- Testing
- APL-2
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Warm Autoimmune Hemolytic Anemia (wAIHA)
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)
Primary Objectives: Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives…
- Trial name
- NCT04661033
- Testing
- Isatuximab SAR650984
- Where
- 6 sites in United States, France and 4 more
- Volunteers
- 8 people
- Sponsor
- Sanofi
Autoimmune Diseases
A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
- Trial name
- NCT04818229
- Testing
- CBP-307, Moxifloxacin (Avelox)
- Where
- 2 sites in United States, Australia
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Connect Biopharma Australia Pty Ltd