Clinical trials: Normal Pregnancy
Atopic Dermatitis (AD), Asthma
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison…
- Trial name
- NCT04173442
- Testing
- dupilumab
- Where
- United States
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
Acute Kidney Injury, Peritonitis
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Trial name
- NCT03403751
- Testing
- Reltecimod 0.5 mg/kg
- Where
- 56 sites in United States, France
- Volunteers
- 58 people
- Sponsor
- Atox Bio Ltd
Solid Tumor Cancer, Solid Tumor, Unspecified, Adult
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.
- Conditions
- Solid Tumor Cancer, Solid Tumor, Unspecified, Adult, Colorectal Carcinoma, Colorectal Carcinoma (CRC)
- Trial name
- DESCENT-1 (NCT06885424)
- Testing
- No additional intervention administered in this long term follow-up study
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- A2 Biotherapeutics Inc.
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
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
Solid Tumors, Urothelial Carcinoma
A Study Evaluating MM-310 in Patients With Solid Tumors
MM-310 is a liposomal formulation of a docetaxel prodrug that targets the EphA2 receptor on cancer cells. Docetaxel is an approved chemotherapeutic drug.This study is a Phase 1 open-label study of MM-310 in patients with solid…
- Conditions
- Solid Tumors, Urothelial Carcinoma, Gastric Carcinoma, Squamous Cell Carcinoma of the Head and Neck
- Trial name
- NCT03076372
- Testing
- MM-310
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Merrimack Pharmaceuticals
Solid Tumors
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors…
- Trial name
- NCT04774952
- Testing
- RMC-5552
- Where
- 8 sites in United States
- Volunteers
- 58 people
- Sponsor
- Revolution Medicines, Inc.
Lupus Nephritis
LUPKYNIS Drug-use Results Survey
The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.
- Trial name
- NCT07053891
- Testing
- Voclosporin (LUPKYNIS)
- Where
- Japan
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
HPV 16- and/or HPV 18-Infected Women With Normal Cytology, ASCUS, or LSIL
Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or…
- Trial name
- NCT02689726
- Testing
- GTL001+, Aldara
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Genticel
Lupus Nephritis
Evaluation of the Tolerance, Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of MIL62 Injection for Treating Lupus Nephritis
This study is composed of two stages: Part A is a randomized, double-blind, placebo-controlled dose-escalation study (i.e., Phase 1b study).
- Trial name
- NCT07044115
- Testing
- Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Where
- China
- Volunteers
- 41 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Renal Impairment
Safety and Pharmacokinetics Study of MBX 2109 in Adult Subjects With Normal and Impaired Renal Function
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
- Trial name
- NCT06496217
- Testing
- MBX 2109
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- MBX Biosciences
Advanced Solid Tumor, Ovarian Cancer
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Ovarian Cancer, Ovary Cancer, Cancer of Ovary
- Trial name
- NCT05252390
- Testing
- NUV-868, Olaparib, Enzalutamide
- Where
- 22 sites in United States, Australia
- Volunteers
- 82 people
- Sponsor
- Nuvation Bio Inc.
Cancer, Solid Tumor Cancer
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies.
- Conditions
- Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer, Prostate
- Trial name
- NCT07424547
- Testing
- SYS6043
- Where
- 5 sites in United States
- Volunteers
- 386 people
- Sponsor
- Conjupro Biotherapeutics, Inc.
Lupus Nephritis
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active…
- Trial name
- ATLAS (NCT01499355)
- Testing
- BIIB023, mycophenolate mofetil, oral corticosteroids
- Where
- 58 sites in United States, Argentina and 19 more
- Volunteers
- 276 people
- Sponsor
- Biogen
Non-small Cell Lung Cancer, Breast Cancer
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma
- Trial name
- NCT04440943
- Testing
- CDX-527
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celldex Therapeutics
Pharmacokinetics, Hepatic Insufficiency
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).
- Conditions
- Pharmacokinetics, Hepatic Insufficiency, Renal Insufficiency
- Trial name
- NCT02894385
- Testing
- BAY1841788
- Where
- 2 sites in Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Bayer
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary objectives of this study were to…
- Trial name
- NCT03400956
- Testing
- Vilaprisan (BAY1002670)
- Where
- 87 sites in United States, Czechia and 3 more
- Volunteers
- 103 people
- Sponsor
- Bayer
Renal Impairment
Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal…
- Trial name
- NCT07857837
- Testing
- Sulthiame
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
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