Clinical trials: Spinal and Bulbar Muscular Atrophy (SBMA)
Spinal and Bulbar Muscular Atrophy
Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.
- Trial name
- NCT03555578
- Testing
- Leuprorelin Acetate
- Where
- Japan
- Volunteers
- 1,905 people
- Sponsor
- Takeda
Metastatic Castration-Resistant Prostate Cancer
Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
This study consists of a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and preliminary efficacy of exicorilant (CORT125281) in combination…
- Trial name
- NCT03437941
- Testing
- Exicorilant, Enzalutamide
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- Corcept Therapeutics
Castration-Resistant Prostate Cancer (CRPC)
A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
A study to assess the safety of continued administration of MDV3100 in subjects with Prostate Cancer who have already undergone treatment with MDV3100 and showed benefit.
- Trial name
- NCT01534052
- Testing
- Enzalutamide
- Where
- 7 sites in United States, Moldova and 1 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Inc
Spinal and Bulbar Muscular Atrophy
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy
The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).
- Trial name
- NCT02024932
- Testing
- BVS857
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer (mCRPC)
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and…
- Trial name
- PSMAndARPI (NCT06894511)
- Testing
- AAA617, ARPI: Abiraterone, ARPI: Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castration Resistant Prostate Cancer
A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer
This clinical trial is evaluating a drug called AC176 in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least one prior systemic therapy.
- Trial name
- NCT05673109
- Testing
- AC176
- Where
- 5 sites in China
- Volunteers
- 8 people
- Sponsor
- Accutar Biotechnology Inc
Prostatic Neoplasms
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC)…
- Trial name
- NCT03523442
- Testing
- Apalutamide
- Where
- 4 sites in China
- Volunteers
- 19 people
- Sponsor
- Janssen Research & Development, LLC
Cachexia
Study to Evaluate the Safety and Efficacy of 13 Weeks of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Chronic Obstructive Pulmonary Disease (COPD)
Impaired physical function and muscle dysfunction are a major consequence of COPD, which may be associated with increased mortality, poor quality of life and increased health care use.
- Trial name
- NCT03359473
- Testing
- GSK2881078
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Prostatic Neoplasms
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care (SOC), versus Standard of Care alone, in adult male patients with Metastatic hormone sensitive prostate…
- Trial name
- PSMAddition (NCT04720157)
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT
- Where
- 164 sites in United States, Austria and 17 more
- Volunteers
- 1,144 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and androgen receptor pathway inhibitor (ARPI) therapy work in participants with prostate gland cancer which has spread to the bone and…
- Trial name
- RADIANT (NCT04597125)
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), ARPI therapy
- Where
- 117 sites in Australia, Austria and 17 more
- Volunteers
- 654 people
- Sponsor
- Bayer
Spinal and Bulbar Muscular Atrophy, Kennedy's Disease
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patients
This is a phase 1/2a randomized, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of study drug AJ201 in subjects with Spinal and Bulbar Muscular Atrophy (SBMA).
- Trial name
- NCT05517603
- Testing
- AJ201
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- AnnJi Pharmaceutical Co., Ltd.
Prostatic Neoplasms
177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the Radiographic progression-free survival (rPFS) or Overall Survival (OS) compared to a change in Androgen receptor-directed therapy (ARDT) in metastatic…
- Trial name
- PSMAfore (NCT04689828)
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, ARDT
- Where
- 72 sites in United States, Austria and 12 more
- Volunteers
- 469 people
- Sponsor
- Novartis Pharmaceuticals
Cachexia
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects
This study is the first administration of GSK2849466 in humans. This will be a single centre, randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics (PK), and…
- Trial name
- NCT01696604
- Testing
- GSK2849466
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Prostate Cancer
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic…
- Trial name
- AcTFirst (NCT06855277)
- Testing
- AAA817, ARPI, Standard of Care
- Where
- 106 sites in United States, Australia and 10 more
- Volunteers
- 940 people
- Sponsor
- Novartis Pharmaceuticals
Acne
Topical ASC-J9 Cream for Acne
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.
- Trial name
- NCT01289574
- Testing
- ASC-J9
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 181 people
- Sponsor
- AndroScience Corp
Prostatic Cancer, Castration-Resistant
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617)…
- Trial name
- NCT07047118
- Testing
- JSB462, AAA617
- Where
- 44 sites in United States, Australia and 13 more
- Volunteers
- 138 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy (SMA)
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial.
- Trial name
- SPECTRUM (NCT05335876)
- Testing
- onasemnogene abeparvovec
- Where
- 32 sites in United States, Australia and 17 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms, Castration-Resistant
A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway…
- Trial name
- NCT07677267
- Where
- United States
- Volunteers
- 1,067 people
- Sponsor
- Novartis Pharmaceuticals
Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive…
- Trial name
- Double-DARE (NCT07406282)
- Testing
- Darolutamide, Abiraterone acetate, Enzalutamide
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Bayer
Cachexia
Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078
GSK2881078 is a selective androgen receptor modulator (SARM) that is being evaluated for effects on muscle growth and strength in subjects with muscle wasting to improve their physical function.
- Trial name
- NCT02567773
- Testing
- GSK2881078, Itraconazole
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline