Phase 2 Lupus Trial, Recruiting (NCT06535412)

Phase 2 Lupus Trial, Recruiting NCT06535412 Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. Condition: Lupus

Printed from Voxsanity (voxsanity.com.au) — NCT06535412 — 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:

You have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 12 weeks before the initial screening appointment
Your lupus is considered active enough to meet a specific disease activity score called SLEDAI-2000, with a score of 8 or higher (confirm with trial site for exact measurement details)
Your lupus shows a certain level of activity across your body systems, based on another scoring tool called BILAG-2004, meaning at least one body system is severely affected or two are moderately affected (confirm with trial site)
If you have skin involvement, your skin symptoms must meet specific characteristics and reach a minimum severity score (confirm with trial site)
You are currently taking at least one standard lupus medication, such as steroid tablets, antimalarial drugs (like hydroxychloroquine), or immune-suppressing medicines
There may be additional requirements set by the trial that are not listed here (confirm with trial site)

Who may not be able to join:

You have active or unstable lupus affecting your brain, nervous system, or kidneys
You have another autoimmune or rheumatic condition in addition to lupus
You have another serious medical condition that is not related to lupus and is not well controlled
You currently have an active or severe infection caused by a virus, bacteria, or fungus
You have had a cancer diagnosis within the last 5 years
There may be additional reasons for exclusion set by the trial that are not listed here (confirm with trial site)

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 22 July 2026

Phase 2: approximately ~30% 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.

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: NCT06535412

Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Phase: Phase 2

Status: Recruiting

Condition: Lupus

More information: https://clinicaltrials.gov/study/NCT06535412

Eligibility summary (AI generated)

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

Who might be able to join this trial:

You have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 12 weeks before the initial screening appointment
Your lupus is considered active enough to meet a specific disease activity score called SLEDAI-2000, with a score of 8 or higher (confirm with trial site for exact measurement details)
Your lupus shows a certain level of activity across your body systems, based on another scoring tool called BILAG-2004, meaning at least one body system is severely affected or two are moderately affected (confirm with trial site)
If you have skin involvement, your skin symptoms must meet specific characteristics and reach a minimum severity score (confirm with trial site)
You are currently taking at least one standard lupus medication, such as steroid tablets, antimalarial drugs (like hydroxychloroquine), or immune-suppressing medicines
There may be additional requirements set by the trial that are not listed here (confirm with trial site)

Who may not be able to join:

You have active or unstable lupus affecting your brain, nervous system, or kidneys
You have another autoimmune or rheumatic condition in addition to lupus
You have another serious medical condition that is not related to lupus and is not well controlled
You currently have an active or severe infection caused by a virus, bacteria, or fungus
You have had a cancer diagnosis within the last 5 years
There may be additional reasons for exclusion set by the trial that are not listed here (confirm with trial site)

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 22 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 2

Sponsor

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

Registry

ClinicalTrials.gov

Start date

10 October 2024

Est. completion

17 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

SLE Responder Index (SRI-4); AEs and SAEs; Pharmacokinetics profiles

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: 22 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