Clinical trials: SC Disease
Type 2 Diabetes Mellitus
Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM
Primary objective: The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.
- Trial name
- NCT01658501
- Testing
- 50 mg PB1023, 70 mg PB1023, 100 mg PB1023
- Where
- 93 sites in United States
- Volunteers
- 593 people
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Post Menopausal Osteoporosis
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when…
- Trial name
- NCT01674621
- Testing
- Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal (150 mcg)
- Where
- 9 sites in United States, Denmark and 2 more
- Volunteers
- 250 people
- Sponsor
- Radius Health, Inc.
Myelodysplastic Syndrome (MDS)
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral…
- Trial name
- NCT04878432
- Testing
- MBG453, Azacitidine, Decitabine
- Where
- 15 sites in United States
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune Encephalitis (AE)
A Study to Learn About How Well the Medicine Efgartigimod Works to Treat Autoimmune Encephalitis In Children 12 Years or Older and Adults
The POLARIS study is designed to evaluate how well efgartigimod PH20 SC may work (called "efficacy") and how safe it is for people diagnosed with Autoimmune Encephalitis (AIE).
- Trial name
- Polaris (NCT07583641)
- Testing
- Efgartigimod PH20 (ARGX-113) SC
- Where
- 2 sites in United States
- Volunteers
- 170 people
- Sponsor
- argenx
Pemphigus Vulgaris, Pemphigus Foliaceus
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult…
- Trial name
- ADDRESS (NCT04598451)
- Testing
- efgartigimod PH20 SC, prednisone
- Where
- 134 sites in United States, Australia and 19 more
- Volunteers
- 222 people
- Sponsor
- argenx
Type 1 Diabetes Mellitus
Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus
Primary Objective: To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a…
- Trial name
- NCT02470637
- Testing
- SAR439065, Insulin lispro
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Mannkind Corporation
HIV Infections, Lymphopenia
Safety Study of IL-7 in HIV-infected Patients (Inspire)
This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T…
- Trial name
- NCT00477321
- Testing
- CYT 107
- Where
- 8 sites in United States, Canada and 2 more
- Volunteers
- 30 people
- Sponsor
- Cytheris SA
Advanced or Metastatic Solid Tumors
A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)
This is a study to assess the pharmacokinetics, safety, and tolerability of pembrolizumab formulated with berahyaluronidase when administered as a SC injection to participants with advanced solid tumors.
- Trial name
- NCT05017012
- Testing
- Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab, Pemetrexed
- Where
- 22 sites in Chile, Hungary and 4 more
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
Inflammatory Bowel Diseases, Crohns Disease
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system for participants with UC or CD. In this study, adults with UC or CD will be treated with vedolizumab according to their clinic's standard…
- Conditions
- Inflammatory Bowel Diseases, Crohns Disease, Colitis, Ulcerative
- Trial name
- NCT04989907
- Where
- 6 sites in Switzerland
- Volunteers
- 92 people
- Sponsor
- Takeda
Anemia
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis.
- Trial name
- MISTRAL (NCT00737477)
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 52 sites in France
- Volunteers
- 96 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus
Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone
Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications for the treatment of diabetes mellitus.
- Trial name
- NCT00862849
- Testing
- Insulin Lispro, Regular Human Insulin, rHuPH20
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Halozyme Therapeutics
Rheumatoid Arthritis
Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)
The study is conducted in order to find out if repeated doses of the monoclonal (artificially manufactured) antibody BT061 can help arthritis patients whose disease does not sufficiently respond to a treatment with methotrexate…
- Trial name
- NCT01481493
- Testing
- BT061
- Where
- 39 sites in Czechia, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- Biotest
Anemia, Sickle Cell, Sickle Cell Anemia
Safety Study of MP4CO in Adult Sickle Cell Patients
Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body.
- Conditions
- Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders
- Trial name
- NCT01356485
- Testing
- MP4CO, Sodium chloride solution
- Where
- 5 sites in France, Jamaica and 2 more
- Volunteers
- 32 people
- Sponsor
- Sangart
Paroxysmal Nocturnal Hemoglobinuria
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants…
- Trial name
- NCT03748823
- Testing
- Ravulizumab OBDS, Ravulizumab
- Where
- 51 sites in United States, Australia and 12 more
- Volunteers
- 139 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hereditary Angioedema
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2.
- Trial name
- NCT01095497
- Testing
- CINRYZE
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- Shire
Immunoglobulin A Nephropathy (IgAN)
A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN
The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.
- Trial name
- Verdant (NCT07773727)
- Testing
- ARGX-121
- Where
- 11 sites in United States, Japan
- Volunteers
- 120 people
- Sponsor
- argenx
Colorectal (Colon or Rectal) Cancer, Adenoma
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial…
- Trial name
- NCT05317351
- Testing
- Standard Colonoscopy, Artificial Intelligence Aided Colonoscopy (GI Genius™), Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
- Where
- 2 sites in United States
- Volunteers
- 2,160 people, healthy volunteers welcome
- Sponsor
- Smart Medical Systems Ltd.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), CIDP
Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options.
- Trial name
- NCT04777734
- Testing
- Efgartigimod PH20 SC
- Sponsor
- argenx
Myasthenia Gravis, Ocular
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis.
- Trial name
- ADAPT oculus (NCT06558279)
- Testing
- Efgartigimod PH20 SC
- Where
- 102 sites in United States, Australia and 23 more
- Volunteers
- 141 people
- Sponsor
- argenx
Primary Immune Thrombocytopenia
Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune…
- Trial name
- NCT06594146
- Testing
- CM313 injection
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Keymed Biosciences Co.Ltd