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

NCT03463187 | Completed Phase 1 FDA Drug

• 1 other identifier: SHR-1314-A201
• Study Type: interventional
• Target: 211
• Locations: 3 countries
• Sites: 13

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.

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (5)

• 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

  From baseline through 24 weeks

• Pharmacokinetics (PK) of SHR-1314 (Part A)

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

  From baseline through 24 weeks

• Pharmacokinetics (PK) of SHR-1314 (Part A)

  Observed Maximum Serum Concentration Following Drug Administration (Cmax)

  From baseline through 24 weeks

• 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%.

  From baseline through 24 weeks

• 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)

  From baseline through 12 weeks

Secondary Outcomes (4)

• Psoriasis Area Severity Index (PASI) score

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

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

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

• Change of dermatology life quality index (DLQI) score

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

• Change from baseline in Body Surface Area (BSA)

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

Study Arms (8)

80mg SHR-1314-Part A

EXPERIMENTAL

SHR-1314 80mg, subcutaneously

Biological: SHR-1314; Drug: Placebo

160mg SHR-1314-Part A

EXPERIMENTAL

SHR-1314 160mg, subcutaneously

Biological: SHR-1314; Drug: Placebo

240mg SHR-1314-Part A

EXPERIMENTAL

SHR-1314 240mg, subcutaneously

Biological: SHR-1314; Drug: Placebo

40mg SHR-1314 (Part B)

EXPERIMENTAL

SHR-1314 40mg, subcutaneously

Biological: SHR-1314

80mg SHR-1314 (Part B)

EXPERIMENTAL

SHR-1314 80mg, subcutaneously

Biological: SHR-1314

160mg SHR-1314 (Part B)

EXPERIMENTAL

SHR-1314 160mg, subcutaneously

Biological: SHR-1314

240mg SHR-1314 (Part B)

EXPERIMENTAL

SHR-1314 240mg, subcutaneously

Biological: SHR-1314

SHR-1314 Placebo (Part B)

EXPERIMENTAL

SHR-1314 Placebo, subcutaneously

Drug: Placebo

Interventions

SHR-1314 BIOLOGICAL

Administered subcutaneously

160mg SHR-1314 (Part B); 160mg SHR-1314-Part A; 240mg SHR-1314 (Part B); 240mg SHR-1314-Part A; 40mg SHR-1314 (Part B); 80mg SHR-1314 (Part B); 80mg SHR-1314-Part A

Placebo DRUG

Administered subcutaneously

160mg SHR-1314-Part A; 240mg SHR-1314-Part A; 80mg SHR-1314-Part A; SHR-1314 Placebo (Part B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent before any study assessment is performed.
• Male or female at least 18 years of age at screening.
• 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.
• Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening.
• Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization.
• 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.
• Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
• History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
• 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.
• History of depression and/or suicidal ideation or behavior which in the opinion of the Investigator, makes the subject unsuitable for clinical study participation.
• Any severe, progressive or uncontrolled medical condition at randomization that in the judgement of the Investigator prevents the subject from participating in the study.
• 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.
• Concurrent or recent use of psoriasis treatments/ medications.
• 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.
• 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.
• 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 \[HBsAb-\].
• History or evidence of active or latent tuberculosis at screening.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (13)

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Revival Research

Doral, Florida, 33122, United States

Location

Indago Research and Health Center - Emergency Medicine

Hialeah, Florida, 33012, United States

Location

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60640, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

St George Dermatology and Skin Cancer Centre - Dermatology

Kogarah, New South Wales, 2217, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Sinclair Dermatology - Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Shanghai Huanshan Hospital Fudan University-Dermatology

Shanghai, 200040, China

Location

Related Publications (1)

• 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.

  PMID: 35026342 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: March 13, 2018
• Study Start: December 15, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

CN (1); US (8); AU (4)