Clinical trials: Biological Therapy
AIDS
Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons
This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection.
- Trial name
- NCT01218113
- Testing
- GSK Biologicals HIV Vaccine 732462
- Where
- 42 sites in United States, France and 2 more
- Volunteers
- 191 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe…
- Trial name
- NCT00750880
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 282 sites in Australia, Austria and 23 more
- Volunteers
- 1,681 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis, Arthritis, Psoriatic
Golimumab Safety and Surveillance Program Using the Ingenix NHI Database
The participants included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to…
- Conditions
- Rheumatoid Arthritis, Arthritis, Psoriatic, Ankylosing Spondylitis
- Trial name
- NCT01081717
- Testing
- systemic non-biological treatments, anti-TNF biologics, golimumab
- Volunteers
- 1,064 people
- Sponsor
- Janssen Biotech, Inc.
Rheumatoid Arthritis
A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced…
- Trial name
- RADAR (NCT01162421)
- Testing
- adalimumab, Methotrexate
- Volunteers
- 77 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hyperlipoproteinemia Type I
Duration of Effect of Alipogene Tiparvovec Treatment, Which Was Administered in Other Studies
LPL (Lipoprotein Lipase) is an enzyme which plays an important role in the elimination of triglycerides (fat) and the clearance of dietary fat particles known as chylomicrons (CM) in the blood.
- Trial name
- NCT01447901
- Where
- Canada
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Amsterdam Molecular Therapeutics
HPV Infection
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV
Conducting an early phase clinical trial to assess HPV Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of HPV patients. 1.
- Trial name
- 9vHPV-BCG (NCT06959563)
- Testing
- 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions (IDD) and to obtain preliminary efficacy…
- Trial name
- NCT00693784
- Testing
- Biostat® Disc Augmentation System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Spinal Restoration, Inc.
Crohn Disease
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant…
- Trial name
- SEAVUE (NCT03464136)
- Testing
- Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)
- Where
- 182 sites in United States, Australia and 16 more
- Volunteers
- 386 people
- Sponsor
- Janssen Scientific Affairs, LLC
Keratitis
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis
The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.
- Trial name
- NCT05250583
- Testing
- LV-Visio-AMTRIX
- Where
- France
- Volunteers
- 5 people
- Sponsor
- TBF Genie Tissulaire
Colorectal Cancer
A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery
This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in…
- Trial name
- NCT05446129
- Testing
- Ezabenlimab, BI 765063, Pembrolizumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Ulcerative Colitis
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC.
- Trial name
- NCT06109441
- Testing
- ALTB-268
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- AltruBio Inc.
Solid Tumors
A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors
A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors
- Trial name
- NCT06826313
- Testing
- VRT106
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
Dermatitis Atopic
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate…
- Trial name
- AQUA (NCT06241118)
- Testing
- Amlitelimab, Topical corticosteroids, Topical tacrolimus or pimecrolimus
- Where
- 154 sites in United States, Argentina and 20 more
- Volunteers
- 464 people
- Sponsor
- Sanofi
Idiopathic Infertility, Infertility Unexplained
Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility
The goal of this clinical trial is to determine whether telomere profiling and other biological aging hallmarks can help identify underlying mechanisms of persistent infertility in women with post-treatment unexplained…
- Conditions
- Idiopathic Infertility, Infertility Unexplained, Infertility (IVF Patients), Infertility Assisted Reproductive Technology
- Trial name
- TECMI (NCT07404969)
- Testing
- 1. Aging Hallmarks Biomarker Profiling (Telomere-Based), 2. Integrative Botanical and Nutraceutical Intervention, 3. Natural Conception or Assisted Reproductive Technologies
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- BEYOND GENOMiX SA, AG, Ltd
Ulcerative Colitis, Active Moderate
Adacolumn in Refractory UC Patients Trial
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients.
- Trial name
- ART (NCT01481142)
- Testing
- (GMA) Adsorptive Apheresis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Arthritis, Psoriatic
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- ICONIC-PsA 1 (NCT06878404)
- Testing
- Icotrokinra, Active reference comparator
- Where
- 155 sites in United States, Argentina and 14 more
- Volunteers
- 552 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B, Chronic
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.
- Trial name
- NCT03866187
- Testing
- ChAd155-hIi-HBV low dose formulation, ChAd155-hIi-HBV high dose formulation, HBc-HBs/AS01B-4 low dose formulation
- Where
- 43 sites in Belgium, France and 7 more
- Volunteers
- 236 people
- Sponsor
- GlaxoSmithKline
Plaque Psoriasis
A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the…
- Trial name
- NCT06030076
- Testing
- Tildrakizumab
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Almirall, S.A.
the Treatment of Knee Osteoarthritis
Intra-articular Administration of Med Device Made of Biological Vegetal Matrix for the Treatment of Knee Osteoarthritis
A pre-market randomized, parallel group, single-blind, clinical study with a Medical Device, made of vegetal material, to evaluate the efficacy and safety of one knee injection of the investigational device versus active…
- Trial name
- NCT05925595
- Testing
- Medical Device Iniettabile Ginocchio
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Bios-Therapy, Physiological Systems for Health S.p.A
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU)
It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of…
- Conditions
- Diabetic Foot Infection, Non-healing Wound, Non-healing Diabetic Foot Ulcer
- Trial name
- NCT04176120
- Testing
- TTAX01, Standard Care
- Where
- 16 sites in United States
- Volunteers
- 220 people
- Sponsor
- BioTissue Holdings, Inc