Clinical trials: Biological Therapy
Rheumatoid Arthritis
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: reduction of signs and symptoms at Week 24 and improvement of physical function at Week 12 in…
- Trial name
- NCT01709578
- Testing
- Sarilumab, hydroxychloroquine, methotrexate
- Where
- 196 sites in United States, Argentina and 28 more
- Volunteers
- 546 people
- Sponsor
- Sanofi
HIV Infections
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1.
- Trial name
- HIVGP-BCG (NCT07182838)
- Testing
- HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Rheumatoid Arthritis
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with…
- Trial name
- ALTERRA (NCT02744196)
- Testing
- Acellbia, Methotrexate
- Volunteers
- 159 people
- Sponsor
- Biocad
Plaque Psoriasis
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
The purpose of the study is to assess the safety and efficacy of an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.
- Trial name
- NCT00832364
- Testing
- Acitretin (also called U0279), Etanercept
- Where
- 3 sites in United States
- Sponsor
- Stiefel, a GSK Company
Rheumatoid Arthritis
Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)
The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications
- Trial name
- NCT01088321
- Volunteers
- 81,332 people
- Sponsor
- Bristol-Myers Squibb
Infertility
Study to Estimate Seedchrony's Predictive Capacity in the Success of Embryo Implantation.
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid…
- Trial name
- Seedchrony02 (NCT06259084)
- Testing
- Seedchrony
- Where
- Spain
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Manina Medtech
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative…
- Trial name
- NCT01424501
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- 6 sites in Estonia, Taiwan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Spinal Cord Injury
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a…
- Trial name
- NCT00500812
- Testing
- Cethrin
- Where
- 8 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Biological Availability
A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form
A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available…
- Trial name
- NCT01267201
- Testing
- methylprednisolone
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Cardiovascular Diseases
Efficacy Study of Pioglitazone and Atorvastatin Combination Therapy in Treating Subjects With Elevated Risk for Cardiovascular Disease
The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and atorvastatin combination therapy compared to atorvastatin monotherapy in patients at risk for cardiovascular disease.
- Trial name
- NCT00770575
- Testing
- Pioglitazone and atorvastatin, Atorvastatin
- Volunteers
- 148 people
- Sponsor
- Takeda
Rheumatoid Arthritis
VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis
This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly…
- Trial name
- VELVET (NCT01390545)
- Testing
- Veltuzumab
- Where
- 63 sites in United States, Argentina and 9 more
- Volunteers
- 300 people
- Sponsor
- Takeda
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Colorectal Cancer
A Study of the Safety and Biological Activity of Intraperitoneal (IP) EGEN-001 Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients
Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune…
- Trial name
- NCT01300858
- Testing
- EGEN-001-301
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- EGEN, Inc.
Pancreatic Cancer
Chemotherapy Compared to Biological Therapy in Treating Patients With Cancer of the Pancreas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.
- Trial name
- NCT00003780
- Testing
- tumor infiltrating lymphocyte therapy, gemcitabine hydrochloride
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Meyer Pharmaceuticals
HIV Seropositivity, HIV Infection
Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300…
- Trial name
- NCT00035581
- Testing
- poly I-poly C12U
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- AIM ImmunoTech Inc.
Punch Biopsy Wounds, Healing Times
Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study
The objective is to determine, if healing of punch biopsy wounds treated with the fish skin derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig intestines derived Oasis Sheet wound dressing.
- Trial name
- NCT01917591
- Testing
- Punch biopsies treated with MariGen Wound ECM dressing, Punch biopsies treated with Oasis ECM dressing
- Where
- Iceland
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Kerecis Ltd.
Non-small Cell Lung Cancer Metastatic
Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer
Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.
- Trial name
- DEEP-Lung-IV (NCT04994795)
- Testing
- Predictive models (data collection)
- Where
- 30 sites in United States, Brazil and 6 more
- Volunteers
- 4,000 people
- Sponsor
- Sophia Genetics SAS
Anterior Cruciate Ligament Rupture
Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
- Trial name
- NCT07129694
- Testing
- Anterior cruciate ligament reconstruction
- Where
- 6 sites in Japan
- Volunteers
- 64 people
- Sponsor
- CoreTissue BioEngineering Inc.
Rheumatoid Arthritis
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment…
- Trial name
- NCT00995449
- Testing
- KB003
- Where
- 11 sites in United States
- Volunteers
- 9 people
- Sponsor
- Humanigen, Inc.
Cancer, Tumor, Solid
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
The purpose of this study is to assess the performance and safety of Biology-Guided Radiotherapy (BgRT) using the RefleXion Medical Radiotherapy System (RMRS) via optimizing F18-Fluorodeoxyglucose (FDG) dosing, assessing the…
- Conditions
- Cancer, Tumor, Solid, Cancer, Lung, Cancer, Bone
- Trial name
- BIOGUIDE-X (NCT04788147)
- Testing
- RMRS IDE Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- RefleXion Medical