NCT05925452

Brief Summary

A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
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

Study Progress53%
Dec 2023Jun 2028

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2028

Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

4.3 years

First QC Date

June 21, 2023

Last Update Submit

September 19, 2024

Conditions

Active Systemic Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with successful glucocorticoid reduction by the end of the treatment period

    24 Week

Study Arms (1)

GenaKumab

EXPERIMENTAL

15 subjects: GenaKumab 3.0mg/kg dose group and 4.0 mg/kg dose group, Subcutaneous injection, Q4w

Drug: GenaKumab

Interventions

GenaKumabDRUG

GenaKumab 3.0mg/kg dose group : GenaKumab 3.0 mg/kg, Subcutaneous injection, Q4w； GenaKumab 4.0 mg/kg dose group : GenaKumab 4.0 mg/kg, Subcutaneous injection, Q4w

GenaKumab

Eligibility Criteria

Age2 Years - 17 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female patients, with the remaining before age 2 years old or more and \& lt; 18 years old;
  • ILAR classification criteria for the diagnosis of confirmed sJIA 2 or more months: onset age must \& lt; At 16 years of age, symptoms included: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° C, body temperature falling below 37 ° C between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; Swelling of the liver and/or spleen; ④ Serositis.
  • Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment.

You may not qualify if:

  • Pregnant or lactating female subjects
  • A history of allergic reactions to investigational drugs or to molecules with similar structures; Those who cannot be given intramuscular injections；
  • History of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; Patients who had been diagnosed with MAS within 6 months prior to screening, or had relevant symptoms and signs at screening, and were suspected of having MAS as assessed by the investigators；
  • There are other rheumatic diseases such as Kawasaki disease, polyarteritis nodosa and so on. History of autoinflammatory diseases such as familial Mediterranean fever, high IgD syndrome, NLRP3-related autoinflammatory diseases；
  • Patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; Patients with a history of repeated invasive fungal infection; In the 7 days prior to randomization, there were infections that required control with systemic antigenic microbiotics (including antibacterial, antiviral, antifungal, etc.)；
  • Subjects with a history of TB exposure or suspected TB symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Children's Hospital Affiliated to Capital Medical University

Beijing, Benjing, 100045, China

RECRUITING

Children's Hospital Affiliated to Chongqing Medical University

Chongqing, Chongqing Municipality, 400015, China

NOT YET RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410323, China

NOT YET RECRUITING

Children's Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215002, China

NOT YET RECRUITING

Affiliated Pediatric Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

NOT YET RECRUITING

Xi'an Children's Hospital

Xi’an, Shanxi, 710002, China

NOT YET RECRUITING

Chengdu Women and Children's Central Hospital

Chengdu, Sichuan, 610073, China

NOT YET RECRUITING

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

NOT YET RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325099, China

NOT YET RECRUITING

Central Study Contacts

Lijun Tang

CONTACT

+86 18570616501tanglijun@genscigroup.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

March 24, 2028

Study Completion (Estimated)

June 29, 2028

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations

CN(10)