Clinical trials: Adalimumab
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Healthy
A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
The purpose of the study is to characterize the inflammatory response to lipopolysaccharide (LPS; molecules that contains fats and carbohydrates) in the presence of a targeted immune pathway modulator.
- Trial name
- NCT05884242
- Testing
- Adalimumab, Lipopolysaccharide (LPS)
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Bioequivalence, Phase 1
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy…
- Trial name
- NCT03273192
- Testing
- Adalimumab
- Where
- Iran
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Inflammatory Bowel Disease (IBD)
Cross Sectional Study of Vaccine Antibody Response in Inflammatory Bowel Disease Patients
The investigators proposed study is the first of its kind. The investigators will measure measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the current IBD treatment modalities and compare the…
- Trial name
- NCT02434133
- Testing
- Blood Draw/Data Collection
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Psoriasis, Atopic Dermatitis
Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3% in the caucasian population of Northern Europe and the US.
- Conditions
- Psoriasis, Atopic Dermatitis, Atherosclerosis
- Trial name
- NCT01356758
- Testing
- biological treatment
- Where
- Denmark
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Pain, Injection Site
Adalimumab Microneedles in Healthy Volunteers
Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA).
- Trial name
- NCT03607903
- Testing
- Adalimumab ID, Adalimumab SC, Saline ID
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centre for Human Drug Research, Netherlands
Crohn's Disease
Anti TNF α Improves Endothelial Dysfunction in IBD Patients
Study hypothesis - this study will assess the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.
- Trial name
- NCT01881464
- Testing
- Endopath from Itamar medical - FDA approved device., Anti TNF Alfa.
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Carmel Medical Center
Healthy
Pharmacokinetics and Safety in Healthy Volunteers
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.
- Trial name
- NCT02045979
- Testing
- BI 695501, adalimumab-EU source, adalimumab-US source
- Where
- 3 sites in Belgium, New Zealand
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used…
- Trial name
- NCT02912247
- Testing
- human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, adalimumab
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS)
SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma…
- Conditions
- Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS), Psoriasis (PsO), Atopic Dermatitis (AD)
- Trial name
- SKINERGY (NCT07021495)
- Where
- 8 sites in Netherlands
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Healthy
Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects
This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.
- Trial name
- NCT02675023
- Testing
- M923
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 603 people, healthy volunteers welcome
- Sponsor
- Momenta Pharmaceuticals, Inc.
Crohn Disease
Biologics and Partial Enteral Nutrition Study
Crohn's disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining. It causes diarrhoea, severe abdominal pain, poor nutrition and adversely affects the quality of life of sufferers.
- Trial name
- BIOPIC (NCT04859088)
- Testing
- Partial Enteral Nutrition
- Where
- 4 sites in United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- NHS Greater Glasgow and Clyde
Healthy Volunteers
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
The main purpose of the study is to demonstrate pharmacokinetic (PK) equivalence of PBP1502 to the European (EU) and American (US) Humira reference products, following a single subcutaneous (SC) dose of 40 mg in healthy…
- Trial name
- NCT05108259
- Testing
- PBP1502, EU-licensed Humira
- Where
- Spain
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Prestige Biopharma Limited
Crohn's Disease, IBD
Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents.
- Trial name
- ENvISION (NCT04131504)
- Testing
- Infliximab, Adalimumab
- Where
- 4 sites in United States
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Adalimumab
A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants
To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the…
- Trial name
- NCT05909852
- Testing
- ABP 501-HCF, ABP 501-LCF
- Where
- 3 sites in United States
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Amgen
Plaque Psoriasis
The Safety & Efficacy of Etanercept in Psoriasis Patients Who Have Not Responded to Adalimumab
To describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis.
- Trial name
- NCT00833729
- Testing
- etanercept
- Where
- Canada
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Dermatrials Research
Psoriasis
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability, Immunogenicity, and Pharmacodynamics (PD) of GSK2800528 in Healthy Subjects.
GSK2800528 is being developed as a human anti-tumor necrosis factor (TNF) alpha monoclonal antibody (mAb) for the treatment of immune-inflammatory diseases.
- Trial name
- NCT01899755
- Testing
- GSK2800528, solution for injection, Adalimumab, solution for injection
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immune System Disorder
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection…
- Trial name
- NCT03357939
- Testing
- HLX03, adalimumab
- Where
- China
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Adult Male
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057…
- Trial name
- NCT07181694
- Testing
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL, Adalimumab (Humira) 100 mg/mL
- Where
- 4 sites in Russia
- Volunteers
- 444 people, healthy volunteers welcome
- Sponsor
- Biocad
Chronic Granulomatous Disease, Crohn'S-like IBD
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
This study will determine if the drug infliximab is safe for treating inflammatory bowel disease (IBD) in patients with chronic granulomatous disease (CGD).
- Conditions
- Chronic Granulomatous Disease, Crohn'S-like IBD, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT00325078
- Testing
- Infliximab
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)