NCT07185269

Brief Summary

This study will evaluate the effect and safety of 626 in patients with SLE

Trial Health

77
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for phase_1

Timeline
30mo left

Started Sep 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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 Progress20%
Sep 2025Nov 2028

First Submitted

Initial submission to the registry

September 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 24, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2028

Last Updated

November 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

September 9, 2025

Last Update Submit

November 25, 2025

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse Events

    Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.

    During the 32- or 36-week study period

Secondary Outcomes (2)

  • SLE Responder Index (SRI-4)

    During the 20- or 24-week treatment period

  • BILAG-based Combined Lupus Assessment (BICLA) Response

    During the 20- or 24-week treatment period

Other Outcomes (3)

  • Peak Plasma Concentration (Cmax)

    During the 32- or 36-week study period

  • Area under the Concentration-Time Curve up to the Last Measurable Concentration（AUC0-last）

    During the 32- or 36-week study period

  • Time to Peak Concentration（Tmax ）

    During the 32- or 36-week study period

Study Arms (7)

Group M1

EXPERIMENTAL

dose level 1 of 626

Drug: 626Drug: Placebo

Group M2

EXPERIMENTAL

dose level 2 of 626

Drug: 626Drug: Placebo

Group M3

EXPERIMENTAL

dose level 3 of 626

Drug: 626Drug: Placebo

Group M4

EXPERIMENTAL

dose level 4 of 626

Drug: 626Drug: Placebo

626 Dose A

EXPERIMENTAL

626 Dose A subcutaneous (SC) injection.

Drug: 626

626 Dose B

EXPERIMENTAL

626 Dose B subcutaneous (SC) injection

Drug: 626

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

626DRUG

626 subcutaneous (SC) injection. Placebo subcutaneous (SC) injection.

Group M1Group M2Group M3Group M4
PlaceboDRUG

Placebo subcutaneous (SC) injection.

Group M1Group M2Group M3Group M4Placebo

Eligibility Criteria

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

You may qualify if:

  • Able to understand protocol requirements and sign a written ICF.
  • Male or female subjects aged 18-70 years when signing the ICF.
  • Body weight between 40 and 90 kg.
  • Diagnosed with SLE at least 6 months before the Screening Visit by a qualified physician，confirmed according to the 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.
  • At screening, meet at least one of the following criteria:
  • Anti-nuclear antibody (ANA) titer ≥ 1:80;
  • Positive anti-dsDNA antibody..
  • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 with clinical SLEDAI score ≥4 points at Screening and Baseline Visit .
  • Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

You may not qualify if:

  • Study participant has a mixed connective tissue disease, and/or overlap syndrome of systemic lupus erythematosus (SLE) with systemic sclerosis.
  • Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition
  • Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
  • History of cancer.
  • Active severe lupus nephritis present within 2 months prior to baseline. Or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2, or protein:creatinine ratio \>2.0 g/g.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Qinghong Zhou

CONTACT

+86 18911301578zhouqinghong@3sbio.com

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

September 9, 2025

First Posted

September 22, 2025

Study Start

September 24, 2025

Primary Completion (Estimated)

August 12, 2028

Study Completion (Estimated)

November 4, 2028

Last Updated

November 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)