NCT06015230

Brief Summary

A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
29mo left

Started Mar 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not 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 Progress63%
Mar 2022Oct 2028

Study Start

First participant enrolled

March 8, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2028

Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

6.3 years

First QC Date

June 1, 2023

Last Update Submit

September 23, 2024

Conditions

Lupus Erythematosus, Systemic

Keywords

IFNRAutoimmune DiseasesSLE

Outcome Measures

Primary Outcomes (2)

  • Adverse events(phase Ib)

    to characterise the safety and tolerability of GR1603,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination

    up to week 16

  • Number of participants who achieved BICLA response (phase Ⅱ)

    BICLA respnse:reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B

    week 24

Secondary Outcomes (12)

  • Cmax(phaseⅠb）

    up to week 16

  • AUC0-t(phaseⅠb）

    up to week 16

  • AUC0-∞(phaseⅠb）

    up to week 16

  • AUCss(phaseⅠb）

    up to week 16

  • Tmax(phaseⅠb）

    up to week 16

  • +7 more secondary outcomes

Study Arms (5)

Treatment group 1-Ⅰb

EXPERIMENTAL

6 subjects in GR1603 low dose，2 subjects in placebo

Biological: low dose GR1603 in phase Ⅰb

Treatment group 2-Ⅰb

EXPERIMENTAL

6 subjects in GR1603 high dose，2 subjects in placebo

Biological: high dose GR1603 in phaseⅠb

treatment group 3-Ⅱ

EXPERIMENTAL

low dose GR1603 monthly

Biological: low dose GR1603 in phase Ⅱ

treatment group 4-Ⅱ

EXPERIMENTAL

high dose GR1603 monthly

Biological: high dose GR1603 in phase Ⅱ

treatment group 5-Ⅱ

PLACEBO COMPARATOR

placebo

Biological: Placebo in phase Ⅱ

Interventions

low dose GR1603 in phase ⅠbBIOLOGICAL

6 subjects in GR1603 low dose，2 subjects in placebo

Treatment group 1-Ⅰb
high dose GR1603 in phaseⅠbBIOLOGICAL

6 subjects in GR1603 high dose，2 subjects in placebo

Treatment group 2-Ⅰb
low dose GR1603 in phase ⅡBIOLOGICAL

low dose GR1603 monthly

treatment group 3-Ⅱ
high dose GR1603 in phase ⅡBIOLOGICAL

high dose GR1603 monthly

treatment group 4-Ⅱ
Placebo in phase ⅡBIOLOGICAL

Placebo

treatment group 5-Ⅱ

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of SLE according to the ACR 1997 ≥24 weeks
  • Active moderate to severe SLE
  • At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.

You may not qualify if:

  • Active severe or unstable neuropsychiatric SLE
  • Clinically significant laboratory test
  • Clinically significant active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union Medical Hosipital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicAutoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Study Officials

  • xiaofeng zeng, PHD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

August 29, 2023

Study Start

March 8, 2022

Primary Completion (Estimated)

June 10, 2028

Study Completion (Estimated)

October 4, 2028

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)