Systemic Lupus ErythematosusPhase 2NCT06791772
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
A Phase 2 study testing CM313 injection in people with Systemic Lupus Erythematosus, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(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?
- CM313 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Feb 2027
- Phase
- Phase 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
- Males or females aged 18 to 65 years.
- Voluntarily signed the informed consent form (ICF).
- Patients were diagnosed with systemic lupus erythematosus(SLE) according to the diagnostic classification criteria of the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019.
- Systemic Lupus Erythematosus Disease Activity Index - 2000(SLEDAI-2K) score ≥6 during screening, and SLEDAI-2K clinical score (except for low complement and/or positive anti-dsDNA antibodies) ≥4 during screening and at baseline.
- Positive antinuclear antibody and/or anti-dsDNA antibody results defined in accordance with the laboratory reference value range of the Central laboratory during the screening.
- ≥1British Isles Lupus Assessment Group-2004 (BILAG-2004) organ system rated as A or ≥ 2 organ system rated as B, and Physician's Global Assessment(PGA) score ≥1.0 during screening.
- Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.
Who cannot join
- Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization.
- Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization.
- There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period.
- History of clinically significant diseases.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Xiaofeng Zeng
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM313(SC) Injection in Subjects With Systemic Lupus Erythematosus
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CM313 injection, Placebo
- 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.
CM313 injectionBiological
CM313 600mg（4ml）/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
CM313 injectionBiological
CM313 600mg（4ml）/vial. Subcutaneous injection 1200mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
PlaceboDrug
Placebo 4 mL/vial. Subcutaneous injection 4 or 8 mL. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | CM313 Receives: Biological: CM313 injection |
| Group B | Experimental | CM313 Receives: Biological: CM313 injection |
| Group C | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
SRI-4 response is defined as:
- Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points
- No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline
- No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline
Measured: Up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (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.
- More trials run by Keymed Biosciences Co.LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Zeng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791772
- Sponsor's protocol ID
- CM313-106106
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM313(SC) Injection in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06791772
- Acronym / sponsor ID
- CM313-106106
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Jan 2025 (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.
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: CM313 injectionCM313 |
| Group B | Experimental | Biological: CM313 injectionCM313 |
| Group C | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females aged 18 to 65 years.
- Voluntarily signed the informed consent form (ICF).
- Patients were diagnosed with systemic lupus erythematosus(SLE) according to the diagnostic classification criteria of the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019.
- Systemic Lupus Erythematosus Disease Activity Index - 2000(SLEDAI-2K) score ≥6 during screening, and SLEDAI-2K clinical score (except for low complement and/or positive anti-dsDNA antibodies) ≥4 during screening and at baseline.
- Positive antinuclear antibody and/or anti-dsDNA antibody results defined in accordance with the laboratory reference value range of the Central laboratory during the screening.
Key exclusion criteria (4 listed)
- Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization.
- Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization.
- There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period.
- History of clinically significant diseases.
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 |
|---|---|---|
| CM313 injectionCM313 600mg（4ml）/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. | Biological | Group A |
| CM313 injectionCM313 600mg（4ml）/vial. Subcutaneous injection 1200mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. | Biological | Group B |
| PlaceboPlacebo 4 mL/vial. Subcutaneous injection 4 or 8 mL. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. | Drug | Group C |
Primary outcome
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)
Time frame: Up to week 24
SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline
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 24 Jan 2025.
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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.
Xiaofeng Zeng principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM313 injection in people with Systemic Lupus Erythematosus, run by Keymed Biosciences 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Jan 2025. 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 phase mean?
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?
Contact Qian Jia (028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) (time frame: Up to week 24). 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 24 Jan 2025.