Clinical trial NCT03704428: Safety, Tolerability and PK of SHR1314 in axSpA
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Axial Spondyloarthritis
Keywords: SHR1314
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.

Detailed description: This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
2. Have a history of back pain ≥3 months with age at onset \<45 years.
3. Have active axSpA defined as BASDAI ≥4 at screening and baseline.
4. Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
5. In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
6. If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

Exclusion Criteria:

1. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
2. Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
3. Total ankylosis of the spine.
4. Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
5. Have either a current diagnosis or a recent history of malignant disease.
6. Are pregnant or breastfeeding.

Primary outcomes:
measure: The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
timeFrame: Baseline to 169 days after dose administration
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of SHR-1314
timeFrame: Baseline to 169 days after dose administration
measure: Time to maximum observed serum concentration (tmax) of SHR-1314
timeFrame: Baseline to 169 days after dose administration
measure: Time to elimination half-life (t1/2) of SHR-1314
timeFrame: Baseline to 169 days after dose administration
measure: Assessment of development of Anti-drug Antibodies (ADAs)
timeFrame: Baseline to 169 days after dose administration
measure: Proportion of Participants Achieving an ASAS20 Response
timeFrame: Week2, 4, 6, 8, 12,16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jianwen Chen
Study officials:
affiliation: People's Liberation Army General Hospital
name: Fei Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Soochow University
name: Xin Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: