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Study on the Efficacy and Safety of Fonakizumab in the Treatment of Patients with Active Psoriatic Arthritis: A Prospective, Single-Arm, Multicenter Clinical Trial

Study on the Efficacy and Safety of Fonakizumab in the Treatment of Patients with Active Psoriatic Arthritis: A Prospective, Single-Arm, Multicenter Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113850
Enrollment
Unknown
Registered
2025-12-03
Start date
2025-12-31
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic arthritis

Interventions

Experimental group:The pertuzumab 240 mg is administered by subcutaneous injection at weeks 0, 2, and 4, followed by dosing every 4 weeks, with the last injection at week 24.

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Study participants voluntarily signed the informed consent form prior to the initiation of the study. 2. At the time of signing the informed consent, participants were aged >=18 and=3 tender joints and >=3 swollen joints). Prior to screening, participants should have been treated with non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks, with inadequate symptom control or intolerance to NSAIDs.

Exclusion criteria

Exclusion criteria: 1. Presence of any of the following medical histories or comorbid conditions: drug-induced psoriasis; other active inflammatory or autoimmune diseases; history of organ transplantation; history of lymphoproliferative disorders; severe infections; malignant tumors; psychiatric disorders, etc. 2. Prior use of any biological agents other than anti-TNF drugs, or prior use of =3 types of anti-TNF drugs. 3. Allergy to any component or excipient of the investigational drug. 4. Pregnancy or lactation in female participants; history of alcohol abuse or illicit drug use, etc. 5. Any other conditions considered by the investigator as inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
ACR20;

Countries

China

Contacts

Public ContactSun Qing

Qilu Hospital of Shandong University

sunqing7226@163.com+86 134 5612 1975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026