Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis
ConditionAxial Spondyloarthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.
About this trial
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Axial Spondyloarthritis
Eligibility criteria
Qualifiers
An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the participant.
Participant is considered reliable and capable of adhering to the protocol (e.g., able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator.
Participant is male or female and at least 18 years of age.
Participant has a documented diagnosis of adult-onset AS as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset <45 years.
Disqualifiers
Female participant who is breastfeeding, pregnant, or planning to become pregnant during the study or within 40 weeks following the final dose of IMP. Male participant planning a partner pregnancy during the study or within 40 weeks following the final dose.
Participant has participated in another study of a medication under investigation within the last 3 months or at least 5 half-lives of the IMP, whichever is greater, or is currently participating in another study of a medication under investigation. Participants who participated in any clinical trial but were enrolled in placebo group and did not receive any IMP in the prior study are eligible for this study.
Participant has received any IL-17 response modifier.
Participant has received more than 3 bDMARDs to treat axSpA.
Trial design
Treatments tested in this trial
- SCT650C
Treatment groups
168 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov