Clinical trials: Biological Therapy
Infections, Rotavirus
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
- Trial name
- NCT00370318
- Testing
- 10 valent pneumococcal conjugate vaccine, Infanrix Hexa, Rotarix
- Where
- 10 sites in Czechia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Osteoarthritis, Knee
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis
The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint…
- Trial name
- NCT04875754
- Testing
- ICM-203
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- ICM Biotech Australia Pty Ltd.
Arthritis, Psoriatic
A Study to Evaluate the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment
Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology.
- Trial name
- PREVAIL (NCT03828045)
- Testing
- Apremilast
- Where
- 20 sites in Spain
- Volunteers
- 119 people
- Sponsor
- Amgen
Pancreatic Cancer
A Study of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
The primary purpose of this study is to assess the safety and effectiveness of TNFerade™ Biologic when administered concurrently with 5-FU and radiation therapy as first-line treatment of unresectable locally advanced pancreatic…
- Trial name
- NCT00051467
- Testing
- TNFerade
- Where
- 25 sites in United States
- Sponsor
- GenVec
Alzheimer Disease
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
- Trial name
- PEGASUS (NCT03533257)
- Testing
- AMX0035
- Where
- 11 sites in United States
- Volunteers
- 95 people
- Sponsor
- Amylyx Pharmaceuticals Inc.
Carcinoma, Renal Cell
Safety and Biological Activity of TroVax® Vaccine Given With IL-2 in Renal Cell Carcinoma
The purpose of this study is to assess the safety and tolerability of TroVax® investigational vaccine injections when given as first or second line treatment in conjunction with subcutaneous low dose IL-2 to patients with locally…
- Trial name
- NCT00325507
- Testing
- TroVax, IL-2
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oxford BioMedica
Asthma
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with…
- Trial name
- AIRLYMPUS (NCT06676319)
- Testing
- Lunsekimig, Short-Acting Beta Agonists (SABA), Fluticasone/Salmeterol
- Where
- 221 sites in United States, Argentina and 20 more
- Volunteers
- 556 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible…
- Trial name
- MAINTAIN (NCT01692899)
- Volunteers
- 780 people
- Sponsor
- Pfizer
Respiratory Disease
A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device
This goal of this study is to assess the suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) device for patients on injectable medications in the home-setting, for the…
- Trial name
- NCT05592769
- Testing
- HealthBeacon Injection Care Management System (ICMS)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- HealthBeacon Plc
Rheumatoid Arthritis
Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional…
- Trial name
- NCT02758769
- Testing
- ORENCIA Subcutaneous Injection
- Where
- 2 sites in Japan
- Volunteers
- 303 people
- Sponsor
- Bristol-Myers Squibb
Obesity
Effect of Shock Wave Therapy Without Biological and Immuno-histochemical Analysis.
Informative Summary: Extracorporeal shockwave therapy (ESWT) is a new method for treating aesthetic disorders within the field of aesthetic medicine, its mechanisms of action and physiological effects promise to combat localized…
- Trial name
- ESWT (NCT05017636)
- Testing
- shock wave therapy
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Indústria Brasileira Equipamentos Médicos - IBRAMED
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Healthy Volunteers
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine…
- Trial name
- NCT01177293
- Testing
- Amlodipine - reference, Amlodipine ODT - test
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteers
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine…
- Trial name
- NCT01138826
- Testing
- Amlodipine - reference, Amlodipine ODT - test
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Psoriatic Arthritis
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over…
- Trial name
- NCT07286058
- Testing
- Zasocitinib
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,182 people
- Sponsor
- Takeda
Breast Cancer
Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer
This is a pilot "window of opportunity" clinical study in patients with operable breast cancer investigating use of reparixin as single agent in the time period between clinical diagnosis and surgery.
- Trial name
- NCT01861054
- Testing
- Reparixin
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dompé Farmaceutici S.p.A
Psoriasis
Exploration of the Cellular and Molecular Mechanisms in Patients Receiving Biotherapies Targeting the IL-23/IL-17 Axis in Cutaneous Psoriasis
This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a monocentric, non randomized prospective study aiming to better understand the mechanisms of the response to…
- Trial name
- Pso23 (NCT05111210)
- Testing
- Blood sample, Data collection, skin biopsies
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Institut Pasteur
Inflammatory Bowel Disease (IBD), Ulcerative Colitis
A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)
This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD).
- Conditions
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's Disease
- Trial name
- NCT05596422
- Where
- 4 sites in Taiwan
- Volunteers
- 423 people
- Sponsor
- Takeda
Psoriasis
Psoriasis Longitudinal Assessment and Registry
The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis.
- Trial name
- PSOLAR (NCT00508547)
- Where
- 320 sites in United States, Argentina and 20 more
- Volunteers
- 21,190 people
- Sponsor
- Janssen Scientific Affairs, LLC
Ovarian Cancer Recurrent
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial…
- Trial name
- NCT03657966
- Testing
- DCVAC/OvCa, Standard of Care Chemotherapy
- Where
- 8 sites in Czechia
- Volunteers
- 33 people
- Sponsor
- SOTIO a.s.