Phase 3 Lupus Trial, Recruiting (NCT07405970)

Phase 3 Lupus Trial, Recruiting NCT07405970 Sponsor: Beijing Mabworks Biotech Co., Ltd. Condition: Lupus

Printed from Voxsanity (voxsanity.com.au) — NCT07405970 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Lupus

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Be between 18 and 80 years old
Have been diagnosed with systemic lupus erythematosus (SLE/lupus) based on recognised international diagnostic guidelines
Have a specific blood test result showing a positive ANA reading of 1:80 or higher, or a positive anti-dsDNA result (types of lupus-related blood markers)
Have active lupus disease at the time of screening, measured as moderately to highly active using a standard lupus scoring system (confirm with trial site)
Currently be on a stable dose of one or more standard lupus medications before the trial starts
Be willing and able to sign a consent form and follow the study rules throughout the trial

Who may not be able to join:

Have poor function of major organs (confirm with trial site for specifics)
Have received rituximab or any similar drug that reduces B-cells in the past 9 months
Have a low level of certain immune cells (CD4+ T cells) in the blood (confirm with trial site)
Have recently received certain immunosuppressant drugs, such as cyclophosphamide (within the past 8 weeks) or specific others including cyclosporine or tacrolimus (within the past 4 weeks)
Have received certain lupus-specific treatments such as Belimumab or Telitacicept within the past 8 weeks
Have received certain other immune-targeting drugs (including TNF inhibitors, JAK inhibitors, or thalidomide, among others) within the past 4 weeks
Have received a live or weakened (attenuated) vaccine in the past 28 days
Have taken part in another clinical trial in the past 28 days
Have another serious medical condition alongside lupus (confirm with trial site)
Test positive for hepatitis B (with raised virus levels in the blood), hepatitis C, or HIV
Have a known history of severe allergic reactions to the study drug MIL62
Are currently pregnant or breastfeeding
Are able to have children but are unwilling or unable to use an acceptable form of contraception during the trial
Have any other condition that the trial doctor believes makes participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 8610-88324172

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07405970

Sponsor: Beijing Mabworks Biotech Co., Ltd.

Phase: Phase 3

Status: Recruiting

Condition: Lupus

Trial contact: 8610-88324172

More information: https://clinicaltrials.gov/study/NCT07405970

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Be between 18 and 80 years old
Have been diagnosed with systemic lupus erythematosus (SLE/lupus) based on recognised international diagnostic guidelines
Have a specific blood test result showing a positive ANA reading of 1:80 or higher, or a positive anti-dsDNA result (types of lupus-related blood markers)
Have active lupus disease at the time of screening, measured as moderately to highly active using a standard lupus scoring system (confirm with trial site)
Currently be on a stable dose of one or more standard lupus medications before the trial starts
Be willing and able to sign a consent form and follow the study rules throughout the trial

Who may not be able to join:

Have poor function of major organs (confirm with trial site for specifics)
Have received rituximab or any similar drug that reduces B-cells in the past 9 months
Have a low level of certain immune cells (CD4+ T cells) in the blood (confirm with trial site)
Have recently received certain immunosuppressant drugs, such as cyclophosphamide (within the past 8 weeks) or specific others including cyclosporine or tacrolimus (within the past 4 weeks)
Have received certain lupus-specific treatments such as Belimumab or Telitacicept within the past 8 weeks
Have received certain other immune-targeting drugs (including TNF inhibitors, JAK inhibitors, or thalidomide, among others) within the past 4 weeks
Have received a live or weakened (attenuated) vaccine in the past 28 days
Have taken part in another clinical trial in the past 28 days
Have another serious medical condition alongside lupus (confirm with trial site)
Test positive for hepatitis B (with raised virus levels in the blood), hepatitis C, or HIV
Have a known history of severe allergic reactions to the study drug MIL62
Are currently pregnant or breastfeeding
Are able to have children but are unwilling or unable to use an acceptable form of contraception during the trial
Have any other condition that the trial doctor believes makes participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Beijing Mabworks Biotech Co., Ltd.

Registry

ClinicalTrials.gov

Start date

10 April 2026

Est. completion

1 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Percentage of participants achieving SRI-4 at Week 52

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov