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CompletedNCT03463187Updated Aug 8, 2023

Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis

A Phase 1/2 interventional study of SHR-1314 and Placebo in Moderate-to-severe Chronic Plaque Psoriasis, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 13 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-08.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2020, 6 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults with moderate-to-severe plaque psoriasis.

Read the detailed description

This study is a multiple dose escalating design to evaluate the safety, PK, and pharmacodynamics (PD) of multiple subcutaneous injections of SHR-1314. There are two parts in this study. The safety, PK, and PD will be evaluated in Part A, the dose escalation part. The efficacy and safety on different doses will be assessed in parallel-groups in Part B.

02

Conditions studied

  • Moderate-to-severe Chronic Plaque Psoriasis
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 570 studies on the registry; 85 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Major Inclusion Criteria:

  1. Provide written informed consent before any study assessment is performed.
  2. Male or female at least 18 years of age at screening.

  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. Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.

Major 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 from randomization.
  4. Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
  5. History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
  6. 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.
  7. History of depression and/or suicidal ideation or behavior which in the opinion of the Investigator, makes the subject unsuitable for clinical study participation.
  8. Any severe, progressive or uncontrolled medical condition at randomization that in the judgement of the Investigator prevents the subject from participating in the study.
  9. 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.
  10. Concurrent or recent use of psoriasis treatments/ medications.
  11. Are currently enrolled in, or discontinued from a clinical trial involving an Investigational product (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.
  12. Have had a live attenuated vaccination within 12 weeks before randomization, or intend to have a live attenuated vaccination during the course of the study, or have participated in a vaccine clinical trial within 12 weeks prior to randomization.

  13. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.

    A positive test for hepatitis B is defined as 1) positive for hepatitis B surface antigen [HBsAg], or 2) positive for anti-hepatitis B core antibody [HBcAb+] but negative for hepatitis B surface antibody [HBsAb-].

  14. History or evidence of active or latent tuberculosis at screening.
  15. Have laboratory test values that are considered clinically significant at screening that, in the opinion of the Investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data.
  16. 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.
  17. Females of child bearing 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 20 weeks after the last administration of investigational product (anticipated 5 half-lives).
  18. History of alcohol or illicit drug abuse within the year prior to screening.
  19. Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study.
  20. Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the Investigator.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
211 participants (actual)

Study arms

  • Experimental
    80mg SHR-1314-Part A

    SHR-1314 80mg, subcutaneously

    Biological: SHR-1314 · Drug: Placebo

  • Experimental
    160mg SHR-1314-Part A

    SHR-1314 160mg, subcutaneously

    Biological: SHR-1314 · Drug: Placebo

  • Experimental
    240mg SHR-1314-Part A

    SHR-1314 240mg, subcutaneously

    Biological: SHR-1314 · Drug: Placebo

  • Experimental
    40mg SHR-1314 (Part B)

    SHR-1314 40mg, subcutaneously

    Biological: SHR-1314

  • Experimental
    80mg SHR-1314 (Part B)

    SHR-1314 80mg, subcutaneously

    Biological: SHR-1314

  • Experimental
    160mg SHR-1314 (Part B)

    SHR-1314 160mg, subcutaneously

    Biological: SHR-1314

  • Experimental
    240mg SHR-1314 (Part B)

    SHR-1314 240mg, subcutaneously

    Biological: SHR-1314

  • Experimental
    SHR-1314 Placebo (Part B)

    SHR-1314 Placebo, subcutaneously

    Drug: Placebo

Interventions

  • BiologicalSHR-1314

    Administered subcutaneously

  • DrugPlacebo

    Administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Number of Participants With Clinically Significant Events (Part A)

    Clinically significant events were defined as abnormal laboratory values and/or adverse events that are related to treatment

    Time frame: From baseline through 24 weeks

  2. Pharmacokinetics (PK) of SHR-1314 (Part A)

    Time to Reach the Maximum Concentration After Drug Administration (Tmax)

    Time frame: From baseline through 24 weeks

  3. Pharmacokinetics (PK) of SHR-1314 (Part A)

    Observed Maximum Serum Concentration Following Drug Administration (Cmax)

    Time frame: From baseline through 24 weeks

  4. Percentage of Participants With Anti-SHR-1314 Antibodies (Part A)

    Percentage of participants with treatment-emergent positive anti-SHR-1314 antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-SHR-1314 antibodies / number of evaluable participants \* 100%.

    Time frame: From baseline through 24 weeks

  5. Percentage of subjects who achieve Psoriasis Area Severity Index (PASI) score 75 (Part B)

    Percentage of subjects who achieve at least 75% improvement in the PASI (PASI 75)

    Time frame: From baseline through 12 weeks

Secondary outcomes

  1. Psoriasis Area Severity Index (PASI) score

    PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as:sum of severity parameters for each region\*area score\*weighing factor (head\[0.1\],upper limbs\[0.2\],trunk\[0.3\],lower limbs \[0.4\]).Overall scores range from 0(no psoriasis) to 72(most severe disease). Percent change from baseline in PASI score over time will be evaluated.

    Time frame: From baseline through 24 weeks (Part A) or 36 weeks (Part B)

  2. Physician's Global Assessment (PGA) of 0 or 1 achievement

    The PGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 \[clear\] to 5 \[severe\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=moderate to severe; 5 = severe). Proportion of subjects achieving PGA response of 0 or 1 over time will be evaluated. PGA response of 0 or 1 is defined as a PGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points on the PGA scale from baseline.

    Time frame: From baseline through 24 weeks (Part A) or 36 weeks (Part B)

  3. Change of dermatology life quality index (DLQI) score

    Change from baseline in DLQI over time. This DLQI is a 10-question patient administered questionnaire that covers six quality of life domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, with total scores ranging from 0-30 (less to more impairment)

    Time frame: From baseline up to 12 weeks (Part A) or 36 weeks (Part B)

  4. Change from baseline in Body Surface Area (BSA)

    Change from baseline in the BSA affected by psoriasis over time.

    Time frame: From baseline through 12 weeks (Part A) or (Part B)

07

Study locations

13 sites
  • Elite Clinical Studies, LLC
    Phoenix, Arizona 85018, United States
  • Anaheim Clinical Trials
    Anaheim, California 92801, United States
  • Revival Research
    Doral, Florida 33122, United States
  • Indago Research and Health Center - Emergency Medicine
    Hialeah, Florida 33012, United States
  • Great Lakes Clinical Trials LLC
    Chicago, Illinois 60640, United States
  • Clinical Partners, LLC
    Johnston, Rhode Island 02919, United States
  • Center for Clinical Studies
    Houston, Texas 77004, United States
  • Center for Clinical Studies
    Webster, Texas 77598, United States
  • St George Dermatology and Skin Cancer Centre - Dermatology
    Kogarah, New South Wales 2217, Australia
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Veracity Clinical Research Pty Ltd
    Woolloongabba, Queensland 4102, Australia
  • Sinclair Dermatology - Dermatology
    East Melbourne, Victoria 3002, Australia
  • Shanghai Huanshan Hospital Fudan University-Dermatology
    Shanghai, 200040, China
08

References and documents

Publications

  • Zhang C, Yan K, Diao Q, Guo Q, Jin H, Yang S, Chen X, Lei T, Wu J, Yu H, Zheng M, Gao X, Sinclair R, Zhu Y, Xu Q, Xu J. A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study evaluating the efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2022 Jul;87(1):95-102. doi: 10.1016/j.jaad.2022.01.005. Epub 2022 Jan 10. PubMed 35026342 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Aug 2020, 32 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Mar 13, 2018
StartActual
Dec 15, 2017
Primary completionActual
Aug 31, 2020
CompletionActual
Aug 31, 2020
Last update
Aug 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03463187
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Mar 13, 2018
Start date
Dec 15, 2017
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Aug 8, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Vunakizumab

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