Clinical trials: Biologic
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Plaque Psoriasis, Biologic Agents
To Explore the Influencing Factors and Solutions for Patients With Plaque Psoriasis Undergoing Relapse
In recent years, an increasing number of patients who have experienced poor efficacy or adverse drug reactions using traditional treatment regimens have received biologic therapy and achieved satisfactory treatment results.
- Conditions
- Plaque Psoriasis, Biologic Agents, Relapse, Influence Factors
- Trial name
- NCT07730619
- Testing
- Diagnosis and Physical Examination of Psoriasis
- Where
- China
- Volunteers
- 140 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Hernia Inguinal, Biologic Mesh
Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal Hernia
Inguinal hernia is one of the most common conditions in general surgery. In clinical practice, surgeons frequently face a dilemma: during the evaluation of a patient with unilateral symptomatic inguinal hernia, a contralateral…
- Trial name
- BiSAH (NCT07649434)
- Testing
- Biologic Mesh, Synthetic Mesh
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Xiangya Hospital of Central South University
Asthma, Immunogenicity
Real-world Immunogenicity of Anti-IL5/5a Antibody
This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.
- Conditions
- Asthma, Immunogenicity, Biologics
- Trial name
- NCT07567690
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
Ulcerative Colitis, Efficacy, Self
Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis
Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis.
- Conditions
- Ulcerative Colitis, Efficacy, Self, Biologics, Mesalazine
- Trial name
- NCT05205603
- Testing
- Infliximab, Vedolizumab, Mesalazine
- Where
- 11 sites in China
- Volunteers
- 438 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Inflammatory Bowel Diseases, Crohn Disease
Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science
Crohn's disease(CD),a type of inflammatory bowel disease(IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Biologics
- Trial name
- NCT05642247
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
ABPA, Biologics
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.
- Conditions
- ABPA, Biologics, Allergic Bronchopulmonary Aspergillosis (ABPA), Cohort Study
- Trial name
- NCT07362693
- Testing
- Biologic Agent
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Qianfoshan Hospital
Immune Thrombocytopenia (ITP), ITP
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Conditions
- Immune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal
- Trial name
- NCT07043946
- Testing
- Budoprutug
- Where
- 20 sites in Bulgaria, Greece and 3 more
- Volunteers
- 24 people
- Sponsor
- Climb Bio, Inc.
Inflammatory Bowel Disease, Heart Rate Variability
Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD
This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du…
- Conditions
- Inflammatory Bowel Disease, Heart Rate Variability, Biologics, Prediction
- Trial name
- NCT07475052
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xijing Hospital
Predicting Biologics Success Via VAT Assessment
Predicting Biologic Therapy Success in Ulcerative Colitis Using Intestinal Ultrasound and Fat Assessment
Our study aimed to detecting biological therapy effectiveness in UC patients using visceral fat assessment
- Trial name
- IBD/VAT (NCT07126015)
- Volunteers
- 200 people
- Sponsor
- Assiut University
Psoriasis, Psoriasis Arthritis
A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist.
- Conditions
- Psoriasis, Psoriasis Arthritis, Biologics
- Trial name
- SMILE (NCT07149792)
- Testing
- Prescreen platform, biologics treatment
- Where
- 2 sites in Taiwan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Taichung Veterans General Hospital
Skin and Connective Tissue Diseases, Skin Diseases
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
Vitiligo is a common acquired depigmentation disorder affecting approximately 2% of the world population. The purpose of this pilot study is to evaluate the effect and the safety of Tildrakizumab in adult participants with…
- Conditions
- Skin and Connective Tissue Diseases, Skin Diseases, Pigmentation Disorder, Hypopigmentation
- Trial name
- TILDVIT-1227 (NCT04971200)
- Testing
- Tildrakizumab
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- Premier Specialists, Australia
Crohn Disease, Child, Only
Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease
Rationale: Crohn's disease (CD) is a chronic, debilitating inflammatory bowel disease (IBD) which is diagnosed during childhood in up to one in ten patients.
- Conditions
- Crohn Disease, Child, Only, Biologic; Inadequate
- Trial name
- ProRAPID (NCT05552287)
- Testing
- Infliximab
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Erasmus Medical Center
Biologic
Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies
This is multicentric, observational, and retro- prospective study.
- Trial name
- NCT05818020
- Where
- 3 sites in Italy
- Volunteers
- 269 people
- Sponsor
- National Cancer Institute, Naples
The Efficacy of Biologics for Stricturing Crohn's Diseases
Biologics for Stricturing Crohn's Diseases
Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective.
- Trial name
- NCT05645055
- Testing
- treat these patients with biologics
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Jinling Hospital, China
Colitis, Ulcerative, Biologics
Tofacitinib Registry of Patients With Ulcerative Colitis in Germany
This registry on Tofacitinib and biologics (anti-integrin/anti-TNF) in the treatment of ulcerative colitis (UC) patients in Germany will extend the prospective documentation of safety issues and efficacy in induction and…
- Conditions
- Colitis, Ulcerative, Biologics, Tofacitiniib, Chronic Inflammatory Small Bowel Disease
- Trial name
- TOFA-UC (NCT04032756)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Ced Service GmbH
Suspected Damage to Fetus From Biologic Agents
Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases
The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children.
- Trial name
- BIOGN1 (NCT04197232)
- Testing
- clinical evaluation
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS San Raffaele
Hernia of Abdominal Wall, Biologic Mesh
Abdominal Wall Repair With Strattice in Germany: a Cohort Study
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients.
- Conditions
- Hernia of Abdominal Wall, Biologic Mesh, Strattice
- Trial name
- BASE cohort (NCT02168231)
- Testing
- Complex abdominal wall repair Strattice
- Where
- 6 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Erasmus Medical Center
Biologic Markers, Clinical Markers
Personalized Needs in Clostridium Difficile Infections
To develop a score that can predict early from diagnosis of Clostridium difficile infection (CDI) the risk for relapse and of unfavorable outcome.
- Trial name
- SPECIFY (NCT02573571)
- Testing
- Development of biomarkers
- Where
- 12 sites in Greece
- Volunteers
- 150 people
- Sponsor
- University of Athens
Hernia of Abdominal Wall, Biologic Implant
The Permacol Dutch Cohort Study
Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients.
- Conditions
- Hernia of Abdominal Wall, Biologic Implant, Infected Hernioplasty Mesh
- Trial name
- NCT02166112
- Testing
- Permacol mesh placement
- Where
- 24 sites in Netherlands
- Volunteers
- 77 people
- Sponsor
- Erasmus Medical Center