Systemic Lupus ErythematosusPhase 1/2NCT06535412
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
A Phase 1/2 study testing IMC-002 + SOC and IMM0306S + SOC in people with Systemic Lupus Erythematosus, run by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- IMC-002 + SOC and IMM0306S + SOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 17 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
- SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.
- BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
- Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
- Other protocol defined inclusion criteria may apply.
Who cannot join
- Active or unstable neuropsychiatric SLE or lupus nephritis
- Autoimmune or rheumatic disease other than SLE
- Significant, uncontrolled medical conditions not related to SLE
- Active and/or severe viral, bacterial or fungal infection
- History of malignancy within 5 years
- Other protocol defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Peking University People's Hospital, +86 010-88324516, pkuphiao@163.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Read the detailed description
This two-stage study consists of a multicenter dose-escalation study（Phase Ib）and a multicenter randomized, double-blind, placebo-controlled study（Phase II）.
Primary objectives of the dose-finding stage: 1) Evaluate the efficacy, safety, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of intravenous IMC-002 and subcutaneous IMM0306S in adult patients with active systemic lupus erythematosus (SLE); 2) Determine the absolute bioavailability of subcutaneous IMM0306S relative to intravenous IMC-002 in adults with moderate-to-severe active SLE; 3) Select the recommended Phase II dose (RP2D).
Primary objectives of the proof-of-concept (PoC) stage: Compare the efficacy of 1.2 mg/kg or 1.6 mg/kg IMC-002 versus placebo in adults with moderate-to-severe active SLE, and assess the efficacy and population PK (popPK) profiles of IMM0306S in patients with active SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- IMC-002 + SOC, Placebo + SOC, IMM0306S + SOC
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-002 + SOCDrug
Also called IMM0306
intravenous injection of 0.8mg/kg、1.2mg/kg and1.6mg/kg
Placebo + SOCDrug
intravenous or subcutaneous injection of Placebo
IMM0306S + SOCDrug
subcutaneous injection of 2.0 mg/kg，4.0 mg/kg and 6.0mg/kg
| Study group | Role | What they receive |
|---|---|---|
| IMC-002 + SOC | Experimental | Not described Receives: Drug: IMC-002 + SOC |
| Placebo + SOC | Placebo comparator | Not described Receives: Drug: Placebo + SOC |
| IMM0306S + SOC | Experimental | Not described Receives: Drug: IMM0306S + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE Responder Index (SRI-4)
Proportion of patients achieving a response in SRI-4
Measured: week 24
AEs and SAEs
The proportion of patients with AEs and SAEs
Measured: week 52
Pharmacokinetics profiles
To characterize PK profiles and absolute bioavailability.
Measured: week 52
Secondary outcomes (9)
SLE Responder Index (SRI-4)
Proportion of patients achieving a response in SRI-4
Measured: week 12 and 52
Lupus Low Disease Activity State (LLDAS)
Proportion of patients achieving a response in LLDAS.
Measured: week 24 and 52
Definition of Remission In SLE (DORIS)
Proportion of patients achieving a response in DORIS.
Measured: week 24 and 52
SLEDAI-2000, PGA, BILAG-2004 and EQ-5D
Changes from baseline in SLEDAI-2000, PGA, BILAG-2004 and EQ-5D.
Measured: week 52
Achieve and sustain a low dose of corticosteroid
Changes in corticosteroid dosage at each visit and proportion of patients who achieve or maintain prednisone ≤ 7.5 mg/d.
Measured: week 52
Achieve low level of urine protein
Changes in 24-hour urinary protein at each visit among trial patients with elevated 24-hour urinary protein at baseline (≥0.5 g) and proportion of patients who achieve to reduce urine protein level.
Measured: week 52
Immunogenicity profiles
Positive rate and titers of anti-drug antibodies (ADA); neutralizing antibodies (NAb) may be further evaluated.
Measured: week 52
Serologic laboratory parameters
Changes from baseline in serologic laboratory parameters (antinuclear antibodies, anti-ds-DNA antibodies, complement C3 and C4).
Measured: week 52
Pharmacodynamic (PD) assessments and biomarker evaluations
Changes in TBNK subsets (CD3, CD4, CD56, CD16, Treg, etc.), B-cell subsets (CD19, CD20, CD27, CD38, CD24, etc.), IL-6 and IgG.
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start10 Oct 2024
- Primary completion17 Dec 2028 (estimated)
- Study completion17 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535412
- Sponsor's protocol ID
- Immuneonco Biotech company
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06535412
- Acronym / sponsor ID
- Immuneonco Biotech company
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.University, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 17 Dec 2028 (estimated)
- Study completion
- 17 Dec 2028 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Detailed description
This two-stage study consists of a multicenter dose-escalation study（Phase Ib）and a multicenter randomized, double-blind, placebo-controlled study（Phase II）.
Primary objectives of the dose-finding stage: 1) Evaluate the efficacy, safety, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of intravenous IMC-002 and subcutaneous IMM0306S in adult patients with active systemic lupus erythematosus (SLE); 2) Determine the absolute bioavailability of subcutaneous IMM0306S relative to intravenous IMC-002 in adults with moderate-to-severe active SLE; 3) Select the recommended Phase II dose (RP2D).
Primary objectives of the proof-of-concept (PoC) stage: Compare the efficacy of 1.2 mg/kg or 1.6 mg/kg IMC-002 versus placebo in adults with moderate-to-severe active SLE, and assess the efficacy and population PK (popPK) profiles of IMM0306S in patients with active SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMC-002 + SOC | Experimental | Drug: IMC-002 + SOC |
| Placebo + SOC | Placebo comparator | Drug: Placebo + SOC |
| IMM0306S + SOC | Experimental | Drug: IMM0306S + SOC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
- SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.
- BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
- Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
- Other protocol defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Active or unstable neuropsychiatric SLE or lupus nephritis
- Autoimmune or rheumatic disease other than SLE
- Significant, uncontrolled medical conditions not related to SLE
- Active and/or severe viral, bacterial or fungal infection
- History of malignancy within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMC-002 + SOCAlso: IMM0306intravenous injection of 0.8mg/kg、1.2mg/kg and1.6mg/kg | Drug | IMC-002 + SOC |
| Placebo + SOCintravenous or subcutaneous injection of Placebo | Drug | Placebo + SOC |
| IMM0306S + SOCsubcutaneous injection of 2.0 mg/kg，4.0 mg/kg and 6.0mg/kg | Drug | IMM0306S + SOC |
Primary outcome
SLE Responder Index (SRI-4)
Time frame: week 24
Proportion of patients achieving a response in SRI-4
AEs and SAEs
Time frame: week 52
The proportion of patients with AEs and SAEs
Pharmacokinetics profiles
Time frame: week 52
To characterize PK profiles and absolute bioavailability.
9 secondary outcomes
SLE Responder Index (SRI-4)
Time frame: week 12 and 52
Lupus Low Disease Activity State (LLDAS)
Time frame: week 24 and 52
Definition of Remission In SLE (DORIS)
Time frame: week 24 and 52
SLEDAI-2000, PGA, BILAG-2004 and EQ-5D
Time frame: week 52
Achieve and sustain a low dose of corticosteroid
Time frame: week 52
Achieve low level of urine protein
Time frame: week 52
Immunogenicity profiles
Time frame: week 52
Serologic laboratory parameters
Time frame: week 52
Pharmacodynamic (PD) assessments and biomarker evaluations
Time frame: week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMC-002 + SOC and IMM0306S + SOC in people with Systemic Lupus Erythematosus, run by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE Responder Index (SRI-4) (time frame: week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.