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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female at age between 18 and 65 years old at screening. 2. 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. 3. 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.
4. A subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy. 5. Body Mass Index (BMI) of 18 to 35 kg/m2 (inclusive) at screening.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening. 2. Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization. 3. 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. 4. History of inflammatory bowel disease or have other ongoing active autoimmune diseases. 5. 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. 6. History of depression and/or suicidal ideation or any suicidal behavior based on clinical assessment by the investigator. 7. 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. 8. 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. 9. 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. 10. 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). 11. History of alcohol or illicit drug abuse within the year prior to screening. 12. Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the Investigator.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03710681
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jiangsu HengRui Medicine Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate-to-severe Plaque Psoriasis
Additional Details

16 subjects with 2 dose groups will be enrolled in the study, all of whom received the SHR-1314 without placebo control. There are 8 subjects in each cohort. The dose will be started at 160mg and will be escalated by following dose escalating rules. The primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Arms & Interventions

Arms

Experimental: Cohort 1

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

Experimental: Cohort 2

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

Interventions

Biological: - SHR-1314

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

Contact a Trial Team

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International Sites

Shanghai, Shanghai, China

Status

Recruiting

Address

Huanshan Hospital , Shanghai Fudan University

Shanghai, Shanghai, 100037

Site Contact

Jinhua Xu, M.D. Ph.D

[email protected]

+86-13818978539

Shanghai, China

Status

Recruiting

Address

Huanshan Hospital , Shanghai Fudan University

Shanghai, , 100037

Site Contact

Jinhua Xu, M.D. Ph.D

[email protected]

+86-13818978539

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