Psoriasis Clinical Trial
Official title:
A Phase I, Partially-randomised, Partially Double-blinded, Safety, Tolerability and Pharmacokinetic Study of ABY-035 in Healthy Subjects and Psoriasis Patients
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to psoriasis patients.
This first in human study with ABY-035 (a novel IL-17A inhibitor (interleukin 17A)) consists
of four Parts. Part A consists of a single ascending intravenous dose study with 40 healthy
volunteers divided into five dose cohorts. Each group consists of 8 subjects where 6 subjects
will receive ABY-035 and 2 will receive placebo. The subjects will be followed for
pharmacokinetic and safety assessments up to Day 95 after dosing.
Part B of the study consists of 6 healthy volunteers who will be given a single subcutaneous
dose of ABY-035. The subjects will follow the same study visit schedule as Part A.
Part C of the study will include up to 12 moderate-to-severe psoriasis patients who each
patient will be given a single intravenous dose of ABY-035. The patients will follow the same
study visit schedule as Part A and B.
Part D of the study will include up to 18 psoriasis patients (mild, moderate or severe). Each
patient will participate in 3 or 7 biweekly dosing occasions of subcutaneously administered
ABY-035. Patients will be followed regularly for safety, efficacy and pharmacokinetics for 8
weeks post-final dose.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03236870 -
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
|
||
| Completed |
NCT00078819 -
Etanercept (Enbrel®) in Psoriasis - Pediatrics
|
Phase 3 | |
| Completed |
NCT04841187 -
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
|
||
| Active, not recruiting |
NCT03927352 -
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT03284879 -
Post-Marketing Surveillance Study of OTEZLA
|
||
| Recruiting |
NCT06027034 -
Effectiveness of a Digital Health Application for Psoriasis
|
N/A | |
| Not yet recruiting |
NCT06050330 -
CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study
|
N/A | |
| Recruiting |
NCT05744466 -
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
|
||
| Completed |
NCT04149587 -
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
|
||
| Completed |
NCT01384630 -
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
|
Phase 2 | |
| Completed |
NCT03998683 -
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
|
Phase 3 | |
| Terminated |
NCT03556202 -
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
|
Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06077331 -
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT04316585 -
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
|
Phase 1 | |
| Completed |
NCT04894890 -
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
|
||
| Completed |
NCT00358384 -
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
|
Phase 1 | |
| Completed |
NCT03757013 -
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
|
||
| Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT05003531 -
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
|
Phase 2 |