Clinical trials: Biological Therapy
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of…
- Trial name
- MIRANDA (NCT06040086)
- Testing
- Tozorakimab
- Where
- 368 sites in United States, Argentina and 27 more
- Volunteers
- 1,454 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the impact of belimumab on immune response to pneumococcal vaccine in subjects with Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT01597492
- Testing
- Belimumab plus Early Vaccination, Belimumab plus Late Vaccination
- Where
- 15 sites in United States
- Volunteers
- 79 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Pulmonary Disease, Chronic Obstructive
Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)
Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with…
- Trial name
- ENDURA-2 (NCT06961214)
- Testing
- Depemokimab
- Where
- 193 sites in United States, Argentina and 14 more
- Volunteers
- 961 people
- Sponsor
- GlaxoSmithKline
Crohn Disease, Colitis, Ulcerative
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult…
- Trial name
- NCT04372108
- Testing
- Ustekinumab, Other Biologic Therapies
- Where
- United States
- Volunteers
- 1,536 people
- Sponsor
- Janssen Scientific Affairs, LLC
Diabetic Retinopathy
HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia
This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study.
- Trial name
- HORNBILL (NCT04424290)
- Testing
- BI 764524
- Where
- 19 sites in United States, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Boehringer Ingelheim
Plaque Psoriasis
Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients
This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e.
- Trial name
- NCT04398732
- Testing
- Enbrel
- Where
- Iraq
- Volunteers
- 486 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.
This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants…
- Trial name
- NCT02679001
- Testing
- TNF inhibitor/TCZ
- Where
- 11 sites in Sweden
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor, Adult
Study of DF9001 in Patients With Advanced Solid Tumors
DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases.
- Trial name
- NCT05597839
- Testing
- DF9001, KEYTRUDA® (pembrolizumab)
- Where
- 17 sites in United States
- Volunteers
- 24 people
- Sponsor
- Dragonfly Therapeutics
ARDS, Human
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS
To evaluate the safety and efficacy of intravenous(IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles(EV), ExoFlo, as treatment for Acute Respiratory Distress Syndrome.
- Trial name
- EXIT-ARDS (NCT05127122)
- Testing
- Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles, Saline
- Sponsor
- Direct Biologics, LLC
Breast Cancer
BN83495 Phase I in Post-menopausal Women
The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or metastatic breast cancer with disease…
- Trial name
- NCT01840488
- Testing
- Irosustat (BN83495)
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 50 people
- Sponsor
- Ipsen
Heart Failure
Efficacy of Candesartan on Brain Natriuretic Peptide Levels in Subjects With Chronic Heart Failure
The purpose of this study is to determine the effects of Candesartan, once daily (QD), added to ongoing chronic heart disease therapy in measuring brain natriuretic peptide in patients with chronic heart failure.
- Trial name
- CANDHEART (NCT00843154)
- Testing
- Candesartan and standard chronic heart disease therapy, Standard chronic heart disease therapy
- Volunteers
- 571 people
- Sponsor
- Takeda
Diabetic Foot Infection, Non-healing Wound
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
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
- NCT04450693
- Testing
- TTAX01, Standard care
- Where
- 16 sites in United States
- Volunteers
- 106 people
- Sponsor
- BioTissue Holdings, Inc
HIV Infections
The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
- Trial name
- NCT00005120
- Testing
- Calanolide A
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- Sarawak MediChem Pharmaceuticals
Non-small Cell Lung Cancer
A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or…
- Trial name
- NCT02439450
- Testing
- Viagenpumatucel-L, Nivolumab, Pembrolizumab
- Where
- 16 sites in United States
- Volunteers
- 121 people
- Sponsor
- Heat Biologics
Cervical Cancer
A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)
This is a Phase 1/2, open-label study of zalifrelimab (AGEN1884) in combination with balstilimab (AGEN2034) in participants with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer.
- Trial name
- NCT03495882
- Testing
- Zalifrelimab, Balstilimab
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 175 people
- Sponsor
- Agenus Inc.
Arthritis, Rheumatoid
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
Part 1 of this trial will assess the safety and effectiveness of subcutaneous (SC) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (DMARD) regimens used in…
- Trial name
- GO-MORE (NCT00975130)
- Testing
- SC golimumab, IV golimumab
- Volunteers
- 3,366 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn Disease
Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's…
- Trial name
- NCT00094458
- Testing
- infliximab (IFX) infusion; azathioprine (AZA) caps
- Where
- 115 sites in United States, Austria and 13 more
- Volunteers
- 508 people
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
Asthma
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .
- Trial name
- HAYATE (NCT05136547)
- Where
- Japan
- Volunteers
- 2,927 people
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a…
- Trial name
- NCT01089023
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 9 sites in Bahrain, Iran and 3 more
- Volunteers
- 95 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis and Crohn's Disease
Entyvio (Vedolizumab) Long Term Safety Study
The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).
- Trial name
- Entyvio PASS (NCT02674308)
- Testing
- Vedolizumab, Other Biologic Agents
- Where
- 287 sites in United States, Austria and 19 more
- Volunteers
- 5,302 people
- Sponsor
- Takeda