Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis

NCT04839016 | Unknown Phase 3 FDA Drug

• 1 other identifier: SHR-1314-301
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis

Conditions

Moderate-to-Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12

  Week 12

• sPGA of 0 or 1 response at Week 12

  Week 12

Secondary Outcomes (3)

• Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12；

  Week 12；

• Percentage of subjects who achieve at least 100% improvement in PASI score (PASI 100) at Week 12

  Week 12

• sPGA of 0 response at Week 12

  Week 12

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR-1314

Treatment group B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1314 DRUG

SHR-1314

Treatment group A

Placebo DRUG

Placebo

Treatment group B

Eligibility Criteria

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

You may qualify if:

• Men or women at least 18 years of age at time of screening.
• Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
• Moderate to severe psoriasis as defined at Baseline/ randomization by:
• PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
• Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
• Body Mass Index (BMI) is 18 kg/m2 or above at screening

You may not qualify if:

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.
• Drug-induced psoriasis.
• Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0).
• 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 congestive heart failure (New York Heart Association \[NYHA\] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
• Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization.
• History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide.
• All subjects will be tested for tuberculosis status using IGRA and X-ray test.
• Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Yang Shen

CONTACT

0518-82342973; Shenyang@hrglobe.cn

Xiaolan Lu

CONTACT

0518-82342973; luxiaolan@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: April 25, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: April 9, 2021

Record last verified: 2021-04