Clinical trials: Biotherapy, open to volunteers
Ulcerative Colitis, Inflammatory Bowel Diseases
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis.
- Trial name
- COMBO-UC (NCT06453317)
- Testing
- Infliximab, Ustekinumab
- Where
- Poland
- Volunteers
- 172 people
- Sponsor
- Medical University of Lodz
Ulcerative Colitis (UC), Crohn's Disease
Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease
This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region.
- Conditions
- Ulcerative Colitis (UC), Crohn's Disease, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT06878495
- Testing
- Discontinuation of 5-ASA
- Volunteers
- 100 people
- Sponsor
- Pusan National University Hospital
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Preoperative Stapokibart for Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps
This is a single-center, randomized, double-blinded, placebo-controlled clinical trial in adults with moderate-to-severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have no previous nasal surgery.
- Trial name
- NCT07616609
- Testing
- Stapokibart
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Beijing Tongren Hospital
Psoriasis Arthritis
A Study of Clinical and Immune Responses to Sequential Biologic Therapies in Psoriatic Arthritis
The goal of this observational study is to evaluate how well advanced therapies work in adults with psoriatic arthritis (PsA) who are starting a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as…
- Trial name
- STRIDE-PsA (NCT07417995)
- Testing
- Biologic or targeted synthetic DMARD (b/tsDMARD)
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Royal United Hospitals Bath NHS Foundation Trust
Crohn Disease, Calprotectin
STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can dramatically affect the quality of life of patients.
- Conditions
- Crohn Disease, Calprotectin, MRI
- Trial name
- Deeper (NCT04973423)
- Testing
- MRI
- Where
- 17 sites in France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Clermont-Ferrand
Chronic Inflammatory Disease
Impact of the Therapeutic Education Program "living with a Chronic Inflammatory Disease Under Biotherapy" on Patient Compliance and Quality of Life
Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence…
- Trial name
- IMPEBIO (NCT06620770)
- Testing
- questionnaires
- Where
- France
- Volunteers
- 126 people
- Sponsor
- Groupe Hospitalier de Bretagne Sud
Ulcerative Colitis
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
- Trial name
- NCT05327790
- Testing
- Lyophilized fecal microbiota (LFMT)
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
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
Stomach Cancer, Stomach Cancer Recurrent
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach…
- Conditions
- Stomach Cancer, Stomach Cancer Recurrent, Stomach Cancer, Adenocarcinoma, Esophageal Cancer
- Trial name
- BAH250 (NCT06532799)
- Testing
- Tumor Infiltrating Lymphocytes (TIL), Cyclophosphamid, Fludarabine
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Essen Biotech
Inflammatory Bowel Diseases, Crohn Disease
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- MOVE-IT (NCT06788340)
- Testing
- PK-model to decide when to dose Vedolizumab and Ustekinumab
- Where
- 6 sites in Denmark
- Volunteers
- 166 people
- Sponsor
- Odense University Hospital
Cancer
Safety and Tolerability of NCP-IL-22BP mRNA in Advanced Solid Tumors
This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor activity of NCP-IL-22BP mRNA, a non-cationic peptide-delivered mRNA encoding…
- Trial name
- NCT07562815
- Testing
- 25 μg NCP-IL-22BP mRNA, 50 μg NCP-IL-22BP mRNA, 100 μg NCP-IL-22BP mRNA
- Where
- China
- Volunteers
- 9 people
- Sponsor
- West China Hospital
Ovary Neoplasm, Ovarian Cancer
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian…
- Conditions
- Ovary Neoplasm, Ovarian Cancer, Epithelial Ovarian Cancer, Recurrent
- Trial name
- NCT06305299
- Testing
- iC9-CAR.B7-H3 T cells, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood.
- Trial name
- TDMpIBD (NCT06954311)
- Where
- 10 sites in Austria
- Volunteers
- 120 people
- Sponsor
- Medical University Innsbruck
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
Inflammatory Bowel Diseases, Crohn Disease
Predicting IBD Treatment Outcomes With Gut Microbiome Analysis
The goal of this prospective observational study is to determine if specific microbiome signatures can predict therapeutic responses in adult patients with Crohn's disease (CD), a form of inflammatory bowel disease (IBD), living…
- Trial name
- OPTIMIST (NCT06453720)
- Testing
- Colonoscopy
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma
Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy…
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
- Trial name
- NCT07383441
- Testing
- Axitinib, Biospecimen Collection, Bone Scan
- Where
- 41 sites in United States
- Volunteers
- 718 people
- Sponsor
- SWOG Cancer Research Network
Asthma, Allergic
Biologics and Sublingual Immunotherapy
Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis.
- Trial name
- BSIPL (NCT06027073)
- Testing
- omalizumab
- Volunteers
- 150 people
- Sponsor
- Medical University of Silesia
Axial Spondyloarthritis (Ankylosing Spondylitis)
Mediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy
This study aims to evaluate the effect of the Mediterranean diet on disease activity, quality of life, inflammation, pain, and treatment response in patients with axial spondyloarthritis (ankylosing spondylitis) who are receiving…
- Trial name
- NCT07170384
- Testing
- Mediterranean Diet, Healthy Eating Advice
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people
- Sponsor
- Sinem Kübra Beke
Cancer
Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors
This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of PAN-NeoVax, an artificial intelligence (AI)-designed pan-cancer…
- Trial name
- NCT07560943
- Testing
- PAN-NeoVax (25 μg), PAN-NeoVax (50 μg), PAN-NeoVax (100 μg)
- Where
- 2 sites in China
- Volunteers
- 9 people
- Sponsor
- West China Hospital
Inflammatory Bowel Disease, Crohn Disease
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency
- Trial name
- NCT04331639
- Testing
- vitamin D3
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Children's Hospital