NCT06299982

Brief Summary

The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2024

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

March 8, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

February 28, 2024

Last Update Submit

March 1, 2024

Conditions

Plaque Psoriasis Patients

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

    At Week 12

  • Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement

    At Week 12

Secondary Outcomes (4)

  • Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

    At Week 12

  • Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100)

    At Week 12

  • Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)

    At Week 12

  • Adverse events (AE)

    20 weeks

Study Arms (2)

608 160 mg W0+80 mg Q2W

EXPERIMENTAL

Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks.

Drug: 608 Q2W

608 160 mg Q4W

EXPERIMENTAL

Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.

Drug: 608 Q4W

Interventions

608 Q2WDRUG

608 160 mg at week 0 + 80 mg Q2W (5 cycles)

608 160 mg W0+80 mg Q2W
608 Q4WDRUG

608 160 mg Q4W (3 cycles)

608 160 mg Q4W

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old, both male and female.
  • Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).

You may not qualify if:

  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) .
  • Other inflammatory diseases.
  • Active autoimmune diseases.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Qinghong Zhou

CONTACT

+86 18911301578zhouqinghong@3sbio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 8, 2024

Study Start

May 15, 2024

Primary Completion

January 30, 2025

Study Completion

March 20, 2025

Last Updated

March 8, 2024

Record last verified: 2024-02