Clinical trials: Biological Therapy
Axial Spondyloarthritis
AScalate: Treat-to-target in Axial Spondyloarthritis
This was a randomized, parallel-group, open-label, multicenter study in patients with active axSpA. The aim of the study was to demonstrate that the efficacy of a T2T approach (with secukinumab as a first-line biologic) was…
- Trial name
- AScalate (NCT03906136)
- Testing
- Secukinumab/Adalimumab-Biosimilar, Standard-of-care
- Where
- 47 sites in France, Germany
- Volunteers
- 304 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels.
- Trial name
- U-EMPOWER (NCT06332534)
- Testing
- Upadacitinib
- Where
- 85 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis
The purpose of this study is to learn how different types of medicines may improve disease activity in people with rheumatoid arthritis (RA). RA is a kind of joint disease that causes pain and swelling.
- Trial name
- NCT06418529
- Testing
- tofacitinib, tumor necrosis factor inhibitors (TNFi), abatacept
- Where
- United States
- Volunteers
- 21,340 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
Safety Study of Abatacept in Rheumatoid Arthritis Participants
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer
- Trial name
- NCT03696173
- Testing
- Non-Interventional
- Where
- United States
- Volunteers
- 5,800 people
- Sponsor
- Bristol-Myers Squibb
Clear Cell RCC
A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients Suffering From Metastatic Renal Cell Carcinoma
This is an open label, single-centre phase 1/2 study involving a single dose of Temferon, an investigational Advanced Therapy Medicinal Product (ATMP), to treat patients with metastatic clear cell renal cell carcinoma (RCC) with…
- Trial name
- TEM-GU (NCT06716853)
- Testing
- Temferon, Pembrolizumab, Cabozantinib
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Genenta Science
Rheumatoid Arthritis
Economic Burden in Adult Patients Diagnosed With Rheumatoid Arthritis (RA) Receiving Treatment With Biologic Disease-modifying Antirheumatic Drugs (bDMARDs)
The purpose of this study is to explore the differences in productivity loss and costs between patients being treated for rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) compared to…
- Trial name
- NCT01136694
- Volunteers
- 695 people
- Sponsor
- Bristol-Myers Squibb
Asthma
Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary…
- Trial name
- imPROve (NCT04184284)
- Where
- 50 sites in Germany
- Volunteers
- 246 people
- Sponsor
- AstraZeneca
Prostate Cancer Metastatic, Hormone Refractory Prostate Cancer
Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters)…
- Conditions
- Prostate Cancer Metastatic, Hormone Refractory Prostate Cancer, Castration-resistant Prostate Cancer
- Trial name
- NCT01487863
- Testing
- sipuleucel-T, abiraterone acetate
- Where
- 21 sites in United States
- Volunteers
- 69 people
- Sponsor
- Dendreon
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy
This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic…
- Trial name
- TOSCA (NCT02001987)
- Testing
- Tocilizumab, Methotrexate, csDMARDs
- Where
- 32 sites in France
- Volunteers
- 139 people
- Sponsor
- Hoffmann-La Roche
Polyarthritis; Rheumatoid
Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
The management of rheumatoid arthritis is based on the prescription of disease-modifying anti-rheumatic drugs (DMARDs) to induce clinical and biological remission.
- Trial name
- NCT06186375
- Testing
- Patients with planned biotherapy
- Where
- 4 sites in France
- Volunteers
- 239 people
- Sponsor
- CEN Biotech
Chronic Plaque Psoriasis
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis
This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.
- Trial name
- VIP-S (NCT02690701)
- Testing
- Secukinumab 300 mg
- Where
- 12 sites in United States
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Comparison of Two Treatment Strategies in Hypertensive Patients
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood…
- Trial name
- NCT00171444
- Testing
- Medical education
- Volunteers
- 4,445 people
- Sponsor
- Novartis
Renal Cell Carcinoma
A Rollover Protocol for Subjects Previously Treated With AGS-003
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
- Trial name
- NCT01482949
- Testing
- AGS-003
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Argos Therapeutics
Solid Tumor, Non Small Cell Lung Cancer
GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or…
- Conditions
- Solid Tumor, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma
- Trial name
- NCT04601402
- Testing
- GEN-001, Avelumab
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Genome & Company
Rheumatoid Arthritis
An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.
This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis.
- Trial name
- NCT02590562
- Testing
- Routine clinical practice
- Where
- 15 sites in China
- Volunteers
- 808 people
- Sponsor
- Hoffmann-La Roche
Wilson Disease, Wilson's Disease
A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)
The purpose of this study is to evaluate the safety, tolerability, biological activity, and initial efficacy of PM577a, an investigational Prime Editing therapy, in adults and adolescents with Wilson disease (WD).
- Conditions
- Wilson Disease, Wilson's Disease, Wilsons Disease
- Trial name
- PM577a (NCT07748403)
- Testing
- PM577a
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 42 people
- Sponsor
- Prime Medicine, Inc.
Determine Effectiveness of Theraskin in the Treatment of DFU and VLU
Clinical Trial to Examine Effectiveness of a Human Allograft for Treatment of DFU and VLU
Retrospective clinical study of 188 patients to examine effectiveness of human cryopreserved allograft in the treatment of diabetic foot ulcers and venous leg ulcers
- Trial name
- NCT03999281
- Testing
- Human Allograft (Theraskin)
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- Solsys Medical LLC
Psoriatic Arthritis
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
- Trial name
- NCT06671483
- Testing
- Zasocitinib, Active Comparator
- Where
- 188 sites in United States, Belgium and 18 more
- Volunteers
- 1,088 people
- Sponsor
- Takeda
Moderate to Severe Rheumatoid Arthritis
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
- Trial name
- ROCkIES (NCT01927757)
- Testing
- Etanercept, Methotrexate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 90 people
- Sponsor
- Amgen
Psoriatic Arthritis (PsA)
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
- Trial name
- KEEPsAKE2 (NCT03671148)
- Testing
- Risankizumab
- Where
- 138 sites in United States, Argentina and 23 more
- Volunteers
- 444 people
- Sponsor
- AbbVie