Clinical trials: Exposure, open to volunteers
Multiple Sclerosis
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks…
- Trial name
- NCT05658497
- Testing
- Diroximel Fumarate, Avonex, Tysabri
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 908 people
- Sponsor
- Biogen
Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy
Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod.
- Trial name
- NCT07732907
- Testing
- Ozanimod
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Bladder Cancer, Urinary Bladder Neoplasms
A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the…
- Trial name
- NCT07222488
- Testing
- MK-3120
- Where
- 17 sites in United States, Austria and 10 more
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as…
- Trial name
- NCT07226986
- Testing
- AMO959, AAA617, Enzalutamide
- Where
- 25 sites in United States, Australia and 5 more
- Volunteers
- 123 people
- Sponsor
- Novartis Pharmaceuticals
Diabetic Kidney Disease, Chronic Kidney Disease
Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product
The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or…
- Trial name
- NCT06790498
- Testing
- Renal Autologous Cell Therapy (REACT)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Prokidney
Precocious Puberty, Gonadotropin-dependent
(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty
The goal of this clinical trial is to evaluate the safety, tolerability, and blood levels of (Z)-endoxifen in girls with McCune-Albright Syndrome that have peripheral precocious puberty.
- Trial name
- NCT07869732
- Testing
- (Z)-endoxifen
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Atossa Therapeutics, Inc.
Metastatic Castration-resistant Prostate Cancer (mCRPC)
PROLONG (PRostateOLaparibONcombinationGcc) Study
The study will generate regionally relevant data to inform clinical practice, support treatment guidelines, and potentially contribute to supportive evidence for health authority discussions or scientific publications.
- Trial name
- PROLONG (NCT07674121)
- Testing
- Olaparib and Abiraterone Combination
- Volunteers
- 75 people
- Sponsor
- AstraZeneca
Influenza, Human, Respiratory Tract Infections
A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants
The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in…
- Conditions
- Influenza, Human, Respiratory Tract Infections, Post-exposure Prophylaxis
- Trial name
- Pearlstone (NCT07827599)
- Testing
- Baloxavir marboxil
- Where
- 8 sites in China
- Volunteers
- 325 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chikungunya Virus Infection
VLA1553-403 Pregnancy Surveillance Study
This post-marketing, observational study evaluates pregnancy and infant outcomes up to 12 weeks after delivery among women who received the chikungunya vaccine (VLA1553) during pregnancy or within 30 days before their last…
- Trial name
- NCT07414524
- Testing
- Live-attenuated CHIKV vaccine VLA1553, Vaccine(s) approved for use during pregnancy by the MoH
- Where
- 3 sites in Brazil
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Pregnancy Related, Pregnancy Complications
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant…
- Conditions
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- Trial name
- NCT05739123
- Testing
- Relugolix-Containing Product
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Multiple Sclerosis
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the…
- Trial name
- NCT05170126
- Where
- 3 sites in United States, Germany
- Volunteers
- 1,182 people
- Sponsor
- Bristol-Myers Squibb
Ultomiris-exposed Pregnant/ Postpartum, Pregnancy
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of…
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS)
- Trial name
- NCT06312644
- Testing
- Ultomiris
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Pregnancy, Obesity
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy
This is an observational cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a…
- Conditions
- Pregnancy, Obesity, Overweight
- Trial name
- NCT05503927
- Testing
- No Intervention
- Where
- 2 sites in United States
- Volunteers
- 2,701 people
- Sponsor
- Novo Nordisk A/S
Psoriasis (PsO)
A Study to Assess Deucravacitinib Safety in Pregnancy
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were…
- Trial name
- NCT07017699
- Testing
- Deucravacitinib, Other systemic treatments for PsO
- Where
- United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Normoglycemia, Prediabetes
Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
The goal of this clinical trial is to investigate the safety and efficacy of Nextida GC-B on glycemic control in adults with normoglycemia and prediabetes.
- Conditions
- Normoglycemia, Prediabetes, Glycemic Control
- Trial name
- NCT07149064
- Testing
- Nextida GC-B
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Rousselot BVBA
Pregnancy Related, Atopic Dermatitis
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
- Trial name
- NCT06627335
- Testing
- Ruxolitinib Cream, TCS
- Where
- United States
- Volunteers
- 5,621 people
- Sponsor
- Incyte Corporation
Migraine
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
- Trial name
- MONITOR (NCT05046613)
- Testing
- Rimegepant, Not taking Rimegepant
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Pfizer
Type II Diabetes Mellitus
Study to Evaluate if Exposure to Drug is Impacted in Participants With Renal Insufficiency
This is an open-label, single-dose, Phase 1 clinical study designed to evaluate the effect of renal impairment on the pharmacokinetics (PK) of GL0034, a long-acting GLP-1 receptor agonist.
- Trial name
- NCT07385547
- Testing
- GL0034
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries Limited
HIV
A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018)
The goal of this study is to learn about the safety of alimatravir (MK-8527) in transgender and gender-diverse people and if they tolerate it.
- Trial name
- EXPrESSIVE-18 (NCT07850609)
- Testing
- Alimatravir
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Biomarkers, Acute Kidney Injury
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
The goal of this observational study is to understand whether a wearable sensor (the Nutromics Sensor Device) can accurately measure drug and biomarker levels in the fluid just under the skin (interstitial fluid), instead of…
- Conditions
- Biomarkers, Acute Kidney Injury, Sepsis
- Trial name
- VENTURE (NCT07893223)
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Nutromics