A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis

NCT03710681 | Unknown Phase 1

• 1 other identifier: SHR-1314-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis. The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.

Conditions

Moderate-to-severe Plaque Psoriasis

Keywords

SHR-1314 Phase 1

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]

  Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram.

  Baseline to 168 days after first dose administration

• Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability]

  Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.

  Baseline to 168 days after first dose administration

Secondary Outcomes (4)

• Assessment of PK parameter

  Baseline to 168 days after first dose administration

• Assessment of PK parameter

  Baseline to 168 days after first dose administration

• Assessment of PK parameter

  Baseline to 168 days after first dose administration

• Assessment of development of Anti-drug Antibodies (ADAs)

  Baseline to 168 days after first dose administration

Study Arms (2)

Cohort 1

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 at 160mg every two weeks

Biological: SHR-1314

Cohort 2

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 at 240mg every two weeks

Biological: SHR-1314

Interventions

SHR-1314 BIOLOGICAL

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at age between 18 and 65 years old at screening.
• History of chronic plaque-type psoriasis for at least 6 months, with either documented medical history of psoriasis for at least 6 months or confirmation of the diagnosis by the Investigator at screening, if the subject was diagnosed by another physician.
• At the time of randomization, moderate to severe plaque psoriasis, defined by:
• PASI score of 12 or greater and
• PGA score of 3 or greater and
• BSA affected by plaque-type psoriasis of 10% or greater.
• A subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
• Body Mass Index (BMI) of 18 to 35 kg/m2 (inclusive) at screening.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening.
• Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization.
• Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior to randomization.
• History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
• At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• History of depression and/or suicidal ideation or any suicidal behavior based on clinical assessment by the investigator.
• Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
• Are currently enrolled in, or discontinued from a clinical trial involving an IP within the last 4 weeks or at least 5 half-lives of the last dosing prior to randomization, whichever is longer; or concurrently enrolled (at randomization) in any other trials.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test at screening or Day 0.
• Females of childbearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use highly effective contraception during the study and 21 weeks after the last administration of IP (anticipated 5 half-lives).
• History of alcohol or illicit drug abuse within the year prior to screening.
• Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the Investigator.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Huanshan Hospital , Shanghai Fudan University

Shanghai, Shanghai Municipality, 100037, China

RECRUITING

Huanshan Hospital , Shanghai Fudan University

Shanghai, 100037, China

RECRUITING

Central Study Contacts

Jianwen Chen, M.D. Ph.D

CONTACT

+86-18036611985; chenjianwen@hrglobe.cn

Qian Xu, M.D. Ph.D

CONTACT

+86- 18721043271; xuqian@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: October 18, 2018
• Study Start: August 2, 2018
• Primary Completion: April 21, 2019
• Study Completion: July 30, 2019
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

CN (2)