Safety, Tolerability and PK of SHR1314 in axSpA

Axial Spondyloarthritis Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704428
• Other study ID #: SHR-1314-AS-102
• Status: Completed
• Phase: Phase 1
• Start date: April 19, 2018
• Est. completion date: January 14, 2020

Study information

• Verified date: January 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

Drug:
• SHR-1314
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Locations

Country	Name	City	State
China	Jianwen Chen	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events.; Incidence of Treatment-Emergent Adverse Events; Incidence of Injection site reaction	Baseline to 169 days after dose administration
Secondary	Maximum observed serum concentration (Cmax) of SHR-1314	maximum concentration (Cmax)	Baseline to 169 days after dose administration
Secondary	Time to maximum observed serum concentration (tmax) of SHR-1314	Time to maximum concentration (Tmax)	Baseline to 169 days after dose administration
Secondary	Time to elimination half-life (t1/2) of SHR-1314	t1/2	Baseline to 169 days after dose administration
Secondary	Assessment of development of Anti-drug Antibodies (ADAs)	Incidence of development of Anti-drug Antibodies (ADAs)	Baseline to 169 days after dose administration
Secondary	Proportion of Participants Achieving an ASAS20 Response	ASAS20 Response	Week2, 4, 6, 8, 12,16