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Moderate-to-severe Chronic Plaque PsoriasisPhase 1/2NCT03463187

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

A Phase 1/2 study testing SHR-1314 in people with Moderate-to-severe Chronic Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd. at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SHR-1314
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
211 participants
Where
13 sitesin 3 countries
Study dates
15 Dec 2017to 31 Aug 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.
  1. 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.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

United States8 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Great Lakes Clinical Trials LLC

    Chicago, Illinois, 60640

  • Revival Research

    Doral, Florida, 33122

  • Indago Research and Health Center - Emergency Medicine

    Hialeah, Florida, 33012

  • Center for Clinical Studies

    Houston, Texas, 77004

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Center for Clinical Studies

    Webster, Texas, 77598

Other trials in United States

Australia4 sites

  • Sinclair Dermatology - Dermatology

    East Melbourne, Victoria, 3002

  • St George Dermatology and Skin Cancer Centre - Dermatology

    Kogarah, New South Wales, 2217

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Veracity Clinical Research Pty Ltd

    Woolloongabba, Queensland, 4102

Other trials in Australia

China1 site

  • Shanghai Huanshan Hospital Fudan University-Dermatology

    Shanghai, 200040

Other trials in China

About this study

Official title: A Multi-Center, Randomized, Double-blind, Placebo-controlled, Multi-Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SHR-1314 With Expanded Dose Finding in Subjects With Moderate-to-severe Plaque Psoriasis

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.

Being tested
SHR-1314, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1314Biological

    Administered subcutaneously

  • PlaceboDrug

    Administered subcutaneously

Study groups in NCT03463187
Study groupRoleWhat they receive
80mg SHR-1314-Part AExperimentalSHR-1314 80mg, subcutaneously
Receives: Biological: SHR-1314; Drug: Placebo
160mg SHR-1314-Part AExperimentalSHR-1314 160mg, subcutaneously
Receives: Biological: SHR-1314; Drug: Placebo
240mg SHR-1314-Part AExperimentalSHR-1314 240mg, subcutaneously
Receives: Biological: SHR-1314; Drug: Placebo
40mg SHR-1314 (Part B)ExperimentalSHR-1314 40mg, subcutaneously
Receives: Biological: SHR-1314
80mg SHR-1314 (Part B)ExperimentalSHR-1314 80mg, subcutaneously
Receives: Biological: SHR-1314
160mg SHR-1314 (Part B)ExperimentalSHR-1314 160mg, subcutaneously
Receives: Biological: SHR-1314
240mg SHR-1314 (Part B)ExperimentalSHR-1314 240mg, subcutaneously
Receives: Biological: SHR-1314
SHR-1314 Placebo (Part B)ExperimentalSHR-1314 Placebo, subcutaneously
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline through 24 weeks

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

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

    Measured: From baseline through 24 weeks

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

    Observed Maximum Serum Concentration Following Drug Administration (Cmax)

    Measured: 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%.

    Measured: 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)

    Measured: From baseline through 12 weeks

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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)

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2018
  2. Study start15 Dec 2017
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
PartA is a multiple dose escalating design in 3 sequential cohorts at 3 dose levels (80mg, 160mg, and 240mg) in plaque psoriasis subjects. Part B is a multiple dose, parallel-group design consisting of 4 treatment arms and 1 placebo arm to assess the efficacy and safety of s.c. injections of SHR-1314 in plaque psoriasis subjects.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03463187
Sponsor's protocol ID
SHR-1314-A201
Status last verified
Aug 2023
First submitted
22 Jan 2018
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1314 in people with Moderate-to-severe Chronic Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd. at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Events (Part A) (time frame: From baseline through 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03463187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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