Clinical trials: Biotherapy
Crohn's Disease
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
- Trial name
- U-EXCEL (NCT03345849)
- Testing
- Upadacitinib
- Where
- 432 sites in United States, Argentina and 47 more
- Volunteers
- 526 people
- Sponsor
- AbbVie
Bacterial Pneumonia
Cx611-0204 SEPCELL Study
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in…
- Trial name
- SEPCELL (NCT03158727)
- Testing
- Cx611
- Where
- 33 sites in Belgium, France and 4 more
- Volunteers
- 84 people
- Sponsor
- Tigenix S.A.U.
Breast Cancer, Ovarian Cancer
A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing
The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).
- Conditions
- Breast Cancer, Ovarian Cancer, Prostate Cancer, Colon Cancer
- Trial name
- NCT00381173
- Testing
- Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Idiopathic Pulmonary Fibrosis
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
- Trial name
- NCT01266135
- Testing
- QAX576
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
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
Focal Epilepsy
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination…
- Trial name
- NCT00855738
- Testing
- Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
- Volunteers
- 111 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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
Ankylosing Spondylitis
Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis
The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis…
- Trial name
- PRETEA (NCT00900796)
- Testing
- Treatment switching
- Where
- Spain
- Volunteers
- 132 people
- Sponsor
- Pfizer
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.
Ulcerative Colitis
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- U-ASTOUND (NCT05782907)
- Testing
- Upadacitinib
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 122 people
- Sponsor
- AbbVie
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
Asthma
Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma
This is a global Phase 2 study divided in two parts. Part A is a double-blind, randomized dose-range finding study in adults with moderate to severe asthma to confirm the dosing regimen of WIN378 that can be tested in future…
- Trial name
- Polaris (NCT07120503)
- Testing
- WIN378
- Where
- 73 sites in United States, Argentina and 6 more
- Volunteers
- 600 people
- Sponsor
- Windward Bio
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
Melanoma (Skin)
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV…
- Trial name
- NCT00012064
- Testing
- therapeutic autologous dendritic cells
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Lisata Therapeutics, Inc.
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
Atopic Dermatitis, Atopic Dermatitis, Unspecified
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or…
- Conditions
- Atopic Dermatitis, Atopic Dermatitis, Unspecified, Dermatitis, Atopic
- Trial name
- NCT06899204
- Testing
- Abrocitinib
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Pfizer
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
Rheumatoid Arthritis
Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists
The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost…
- Trial name
- NCT01040715
- Testing
- TNFa Kinoid, TNF kinoid
- Where
- 35 sites in Argentina, Belgium and 5 more
- Volunteers
- 40 people
- Sponsor
- Neovacs
Kidney Cancer
Vaccine Therapy in Treating Patients With Kidney Cancer
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.
- Trial name
- NCT00014131
- Testing
- Biological/Vaccine: therapeutic autologous dendritic cells.
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Lisata Therapeutics, Inc.