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Trial record 3 of 4 for:    shr-1314 | psoriasis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463187
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Moderate-to-severe Chronic Plaque Psoriasis Biological: SHR-1314 Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : May 27, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 80mg SHR-1314-Part A
SHR-1314 80mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Drug: Placebo
Administered subcutaneously

Experimental: 160mg SHR-1314-Part A
SHR-1314 160mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Drug: Placebo
Administered subcutaneously

Experimental: 240mg SHR-1314-Part A
SHR-1314 240mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Drug: Placebo
Administered subcutaneously

Experimental: 40mg SHR-1314 (Part B)
SHR-1314 40mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Experimental: 80mg SHR-1314 (Part B)
SHR-1314 80mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Experimental: 160mg SHR-1314 (Part B)
SHR-1314 160mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Experimental: 240mg SHR-1314 (Part B)
SHR-1314 240mg, subcutaneously
Biological: SHR-1314
Administered subcutaneously

Experimental: SHR-1314 Placebo (Part B)
SHR-1314 Placebo, subcutaneously
Drug: Placebo
Administered subcutaneously




Primary Outcome Measures :
  1. Number of Participants With Clinically Significant Events (Part A) [ Time Frame: From baseline through 24 weeks ]
    Clinically significant events were defined as abnormal laboratory values and/or adverse events that are related to treatment

  2. Pharmacokinetics (PK) of SHR-1314 (Part A) [ Time Frame: From baseline through 24 weeks ]
    Time to Reach the Maximum Concentration After Drug Administration (Tmax)

  3. Pharmacokinetics (PK) of SHR-1314 (Part A) [ Time Frame: From baseline through 24 weeks ]
    Observed Maximum Serum Concentration Following Drug Administration (Cmax)

  4. Percentage of Participants With Anti-SHR-1314 Antibodies (Part A) [ Time Frame: From baseline through 24 weeks ]
    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%.

  5. Percentage of subjects who achieve Psoriasis Area Severity Index (PASI) score 75 (Part B) [ Time Frame: From baseline through 12 weeks ]
    Percentage of subjects who achieve at least 75% improvement in the PASI (PASI 75)


Secondary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) score [ Time Frame: From baseline through 24 weeks (Part A) or 36 weeks (Part B) ]
    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.

  2. Physician's Global Assessment (PGA) of 0 or 1 achievement [ Time Frame: From baseline through 24 weeks (Part A) or 36 weeks (Part B) ]
    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.

  3. Change of dermatology life quality index (DLQI) score [ Time Frame: From baseline up to 12 weeks (Part A) or 36 weeks (Part B) ]
    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)

  4. Change from baseline in Body Surface Area (BSA) [ Time Frame: From baseline through 12 weeks (Part A) or (Part B) ]
    Change from baseline in the BSA affected by psoriasis over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT03463187


Contacts
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Contact: Jianwen Chen, MD. Ph.D. +0186 18036611985 chenjianwen@hrglobe.cn
Contact: Qian Xu, MD. Ph.D. +0186 18721043271 xuqian@hrglobe.cn

Locations
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United States, Arizona
Elite Clinical Studies, LLC Recruiting
Phoenix, Arizona, United States, 85018
Contact: Joseph Lillo    602-788-3437    joseph@eliteclinicalstudies.com   
United States, California
Anaheim Clinical Trials Recruiting
Anaheim, California, United States, 92801
Contact: Amina Haggag, MD    714-774-7777    ahaggag@act-trials.com   
United States, Florida
Revival Research Recruiting
Doral, Florida, United States, 33122
Contact: Delilah Alonso, MD    305-982-8892      
Indago Research and Health Center - Emergency Medicine Recruiting
Hialeah, Florida, United States, 33012
Contact: Jose Cardona, MD    305-825-6588      
United States, Illinois
Great Lakes Clinical Trials LLC Recruiting
Chicago, Illinois, United States, 60640
Contact: Amin Ahmad    773-275-3500      
United States, Rhode Island
Clinical Partners, LLC Recruiting
Johnston, Rhode Island, United States, 02919
Contact: Ellen Frankel    401-454-3800    dr.frankel@riskindoc.com   
United States, Texas
Center for Clinical Studies Recruiting
Houston, Texas, United States, 77004
Contact: Stephen Tyring    713-528-8818      
Center for Clinical Studies Recruiting
Webster, Texas, United States, 77598
Contact: Patricia Lee, MD    281-333-2228      
Australia, New South Wales
St George Dermatology and Skin Cancer Centre - Dermatology Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Stephen Shumack, MD    (02) 95874277      
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Penas Pablo Fernandez, MD         
Australia, Queensland
Veracity Clinical Research Pty Ltd Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Lynda Spelman, MD         
Australia, Victoria
Sinclair Dermatology - Dermatology Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Rodney Sinclair, MD    +61-3-94213507      
China
Shanghai Huanshan Hospital Fudan University-Dermatology Recruiting
Shanghai, China, 200040
Contact: Jinhua Xu, MD    +86 21552887781    xjhhsyy@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Chair: Jianwen Chen, MD. Ph.D. Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03463187     History of Changes
Other Study ID Numbers: SHR-1314-A201
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases