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

NCT ID: NCT03463187

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2020-08-31

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.

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.

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

80mg SHR-1314-Part A

SHR-1314 80mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

Placebo

Intervention Type: DRUG

Administered subcutaneously

160mg SHR-1314-Part A

SHR-1314 160mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

Placebo

Intervention Type: DRUG

Administered subcutaneously

240mg SHR-1314-Part A

SHR-1314 240mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

Placebo

Intervention Type: DRUG

Administered subcutaneously

40mg SHR-1314 (Part B)

SHR-1314 40mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

80mg SHR-1314 (Part B)

SHR-1314 80mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

160mg SHR-1314 (Part B)

SHR-1314 160mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

240mg SHR-1314 (Part B)

SHR-1314 240mg, subcutaneously

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: BIOLOGICAL

Administered subcutaneously

SHR-1314 Placebo (Part B)

SHR-1314 Placebo, subcutaneously

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Administered subcutaneously

Interventions

SHR-1314

Administered subcutaneously

Intervention Type: BIOLOGICAL

Placebo

Administered subcutaneously

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

Revival Research

Doral, Florida, United States

Indago Research and Health Center - Emergency Medicine

Hialeah, Florida, United States

Great Lakes Clinical Trials LLC

Chicago, Illinois, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Center for Clinical Studies

Houston, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

St George Dermatology and Skin Cancer Centre - Dermatology

Kogarah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

Sinclair Dermatology - Dermatology

East Melbourne, Victoria, Australia

Shanghai Huanshan Hospital Fudan University-Dermatology

Shanghai, , China

Countries

United States; Australia; China

References

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.

Reference Type: DERIVED

PMID: 35026342 (View on PubMed)

Other Identifiers

SHR-1314-A201

Identifier Type: -

Identifier Source: org_study_id