Clinical trial • Phase I • Immunology
Risankizumab for Psoriatic arthritis | Crohn's disease | Plaque psoriasis | Ulcerative colitis
Phase I trial of Risankizumab for Psoriatic arthritis | Crohn's disease | Plaque psoriasis | Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Psoriatic arthritis | Crohn's disease | Plaque psoriasis | Ulcerative colitis
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 03-07-2025
- First CTIS Authorization Date
- 26-10-2025
Trial design
CKD-704 (risankizumab biosimilar) vs EU-approved Skyrizi® and US licensed Skyrizi®; doses and schedules not specified in provided documents.-controlled Phase I trial across 1 site in Poland.
- Comparator
- CKD-704 (risankizumab biosimilar) vs EU-approved Skyrizi® and US licensed Skyrizi®; doses and schedules not specified in provided documents.
- Target Sample Size
- 213
Eligibility
Recruits 213 Vulnerable population selected (isVulnerablePopulationSelected = true) in CTIS record; no further details provided on which vulnerable groups, or on consent/assent procedures..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true) in CTIS record; no further details provided on which vulnerable groups, or on consent/assent procedures.
Recruitment
- Planned Sample Size
- 213
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 213
Poland
- Earliest CTIS Part Ii Submission Date
- 02-10-2025
- Latest Decision Or Authorization Date
- 26-10-2025
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 213
Sites
- Site Name
- Mtz Clinical Research Powered By Pratia
- Contact Person Name
- Anna Dryja
- Contact Person Email
- anna.dryja@pratia.com
- Number Of Participants
- 213
Sponsor
Primary sponsor
- Full Name
- Chong Kun Dang Pharmaceutical Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Korea, Republic of
Investigational products
- Investigational Product Name
- CKD-704 (risankizumab biosimilar)
- Active Substance
- Risankizumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Skyrizi® (EU-approved Skyrizi®)
- Active Substance
- Risankizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- EU-approved
- Investigational Product Name
- Skyrizi® (US licensed Skyrizi®)
- Active Substance
- Risankizumab
- Modality
- Monoclonal antibody
- Authorisation Status
- US licensed
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