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Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis

NCT05046431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 704

Last updated 2023-10-12

No results posted yet for this study

Summary

This is a multicenter, double-blind, randomized, parallel-group study to compare the efficacy,pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity of BAT2506 versus Simponi® in participants with active PsA.

The study will consist of up to 4-week Screening Period, a 52-week Treatment Period, and a 8-week Safety Follow-up Period.

Conditions

Interventions

DRUG

BAT2506

50mg/0.5mL

DRUG

EU Simponi

50mg/0.5mL

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2023-10-06
Completion
2023-10-06

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046431 on ClinicalTrials.gov