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Trial record 2 of 4 for:    shr-1314 | psoriasis

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

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ClinicalTrials.gov Identifier: NCT03710681
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Moderate-to-severe Plaque Psoriasis Biological: SHR-1314 Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : April 21, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Cohort 1
Multiple subcutaneous injections of SHR-1314 at 160mg every two weeks
Biological: SHR-1314
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Experimental: Cohort 2
Multiple subcutaneous injections of SHR-1314 at 240mg every two weeks
Biological: SHR-1314
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.




Primary Outcome Measures :
  1. Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability] [ Time Frame: Baseline to 168 days after first dose administration ]
    Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram.

  2. Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability] [ Time Frame: Baseline to 168 days after first dose administration ]
    Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.


Secondary Outcome Measures :
  1. Assessment of PK parameter [ Time Frame: Baseline to 168 days after first dose administration ]
    time to maximum concentration (tmax)

  2. Assessment of PK parameter [ Time Frame: Baseline to 168 days after first dose administration ]
    maximum concentration (Cmax)

  3. Assessment of PK parameter [ Time Frame: Baseline to 168 days after first dose administration ]
    area under curve (AUC0-14days)

  4. Assessment of development of Anti-drug Antibodies (ADAs) [ Time Frame: Baseline to 168 days after first dose administration ]
    Incidence of development of Anti-drug Antibodies (ADAs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710681


Contacts
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Contact: Jianwen Chen, M.D. Ph.D +86-18036611985 chenjianwen@hrglobe.cn
Contact: Qian Xu, M.D. Ph.D +86- 18721043271 xuqian@hrglobe.cn

Locations
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China, Shanghai
Huanshan Hospital , Shanghai Fudan University Recruiting
Shanghai, Shanghai, China, 100037
Contact: Jinhua Xu, M.D. Ph.D    +86-13818978539    xjhhsyy@163.com   
Contact: Guoying Cao, M.D. Master    +86-13651900963    sherley_76@163.com   
China
Huanshan Hospital , Shanghai Fudan University Recruiting
Shanghai, China, 100037
Contact: Jinhua Xu, M.D. Ph.D    +86-13818978539    xjhhsyy@163.com   
Contact: Guoying Cao, M.D. Master    +86-13651900963    sherley_76@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03710681     History of Changes
Other Study ID Numbers: SHR-1314-103
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR-1314 Phase 1
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases