Clinical trials: Adalimumab
Healthy
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects
- Trial name
- NCT03970824
- Testing
- CT-P17, US-licensed Humira, EU-approved Humira
- Where
- 9 sites in South Korea
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Celltrion
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
Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA
Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.
- Trial name
- ADIBD (NCT01860963)
- Testing
- Anal Pap smear and HPV DNA testing
- Where
- United States
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Stanford University
Rheumatoid Arthritis
The ArthritisPower Wearable Study
Rheumatoid arthritis patients being seen at one of the participating clinical sites in a U.S. network of community rheumatology practices who are starting treatment on adalimumab or upadacitinib will be enrolled into a 24-week…
- Trial name
- WEAR (NCT05603806)
- Where
- United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Global Healthy Living Foundation
Crohn Disease, Ulcerative Colitis
Multi-omics to Predict Responses to Biologics in IBD
Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).
- Trial name
- MORE (NCT05542459)
- Testing
- Biologics
- Where
- China
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
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
Immunoclassification, Psoriasis
Immunoclassification of Psoriasis: a Strategy for Precision Medicine
Through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide…
- Trial name
- NCT05503875
- Testing
- adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase 1
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in…
- Trial name
- NCT03983876
- Testing
- Adalimumab
- Where
- 2 sites in New Zealand
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Healthy
Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and…
- Trial name
- NCT02395055
- Testing
- Adalimumab (BCD-057), Adalimumab (Humira)
- Where
- Russia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Biocad
Vogt Koyanagi Harada Disease (VKH)
Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).
- Trial name
- NCT05120687
- Testing
- noncorticosteroid systemic immunomodulatory therapy (NCSIT)
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Healthy Participants
A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions
A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under…
- Trial name
- NCT07147257
- Testing
- CHS-1420, HUMIRA®
- Where
- China
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
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.
Innate Immunity
Effect of Anti-Inflammatory Agents on Biological Responses to Endotoxin Inhalation in Healthy Subjects
The main objective of this study is to characterize the biological responses elicited by endotoxin inhalation applied to healthy subjects, and to assess the effect of standard anti-inflammatory agents (i.e.
- Trial name
- NCT02252809
- Testing
- adalimumab, methylprednisolone
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Brugmann University Hospital
Rheumatoid Arthritis
Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary disease, stroke, heart failure etc.) have already…
- Trial name
- NCT01954381
- Testing
- transthoracic echocardiographic, Doppler ultrasound., blood samples
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Assistance Publique Hopitaux De Marseille
Healthy Subjects
MSB11022 in Healthy Subjects
This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.
- Trial name
- NCT03014947
- Testing
- MSB11022, US-licensed Humira, EU-approved Humira
- Volunteers
- 237 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH