Systemic Lupus ErythematosusPhase 1NCT05866861
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
A Phase 1 study testing CUG252 in people with Systemic Lupus Erythematosus and SLE (Systemic Lupus), run by Cugene Inc. at 11 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with 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, SLE (Systemic Lupus), Autoimmune
- What is being tested?
- CUG252
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Apr 2023to 1 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female participant, aged 18 to 65 years (inclusive), at time of consent
- BMI greater than or equal to 18 and less than 39 kg/m2 at Screening
- Diagnosis of SLE at least 6 months prior to Screening
- Minimal to moderate SLE disease activity
- If a participant is taking oral prednisone, the dose must be less than or equal to 20 mg/day for a minimum of 8 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening
- If a participant is taking azathioprine, antimalarial, mycophenolate mofetil, or methotrexate, the medication(s) must have been started a minimum of 12 weeks prior to Screening and at a stable dose for a minimum of 8 weeks prior to Screening
Who cannot join
- Have one or more of the following medical conditions: SARS-CoV-2 infection 30 days prior to drug administration, evidence of Grade 3 or greater hematologic, hepatic, or rental dysfunction, active severe or unstable neuropsychiatric SLE, active severe renal disease, history of severe active lupus nephritis with proteinuria levels greater than 1.0 g/24 hours, or dialysis in the last 6 months. History of current diagnosis of other autoimmune/inflammatory diseases, history of any non-SLE disease that has required treatment with corticosteroids for more than 2 weeks within the last 12 weeks prior to Screening, active clinically significant bacterial, viral, or fungal infection at Screening, active or latent TB at Screening, pulmonary infection or active lung disease besides those related to lupus, or severe pulmonary disease requiring oxygen therapy. History of condition that predisposes participant to infection, confirmed positive serology at Screening, history of opportunistic infection requiring hospitalization or IV antimicrobial treatment within the last year, history of organ or hematopoietic stem cell transplant, history of major surgery within 12 weeks of Screening, history of significant cardiovascular disease, history of gastrointestinal bleeding, history of cancer apart from successfully treated squamous or basal cell carcinoma or cervical cancer in situ.
- Are on one or more of the following medications: have received vaccination within 30 days prior to Screening (including COVID-19 vaccination), Aldesleukin or other IL-2 derivatives at any time, T cell depleting agents and inhibitors of T cell activation at any time, Anti-BLyS/BAFF inhibitors, IL-1 receptor antagonist, anti-TNF therapy, and anti-interferon alpha receptor inhibitor within 3 months prior to Screening, rituximab or other B-cell depleting agent within 6 months, glucocorticoids within 6 weeks prior to Day 1, other immunosuppressant drugs within 8 weeks, history of cytotoxic medications within 12 months, receipt of blood products within 6 months, plasmapheresis within 30 days of Screening.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Site 1001
Anniston, Alabama, 36207
Site 1002
Clearwater, Florida, 33765
Site 1010
Columbus, Ohio, 44106
Site 1006
Dallas, Texas, 75231
Site 1003
Duncansville, Pennsylvania, 16635
Site 1011
La Jolla, California, 92037
Site 1007
Lawrenceville, Georgia, 30046
Site 1004
Mesquite, Texas, 75150
Site 1005
Middleburg Heights, Ohio, 44130
Site 1012
Seattle, Washington, 98195
Site 1009
Tampa, Florida, 33606
About this study
Official title: A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following Multiple Dose Administrations in Participants With Mild-to-Moderate SLE
The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
Read the detailed description
CUG252 is a potential best-in-class engineered IL-2 compound, designed to have improved Treg selectivity while reducing undesired IL-2 activity.
This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunologic effects of CUG252 following subcutaneous administration of multiple ascending doses in participants with mild-to-moderate SLE. The effects of SLE disease activity and biomarkers will also be evaluated.. The SLE participants will receive randomized multiple subcutaneous doses of CUG252 or placebo. After receiving the last dose of CUG252 or placebo, participants will be followed to study day 64 post first dose administration to evaluate safety, PK, PD and preliminary efficacy.
- Being tested
- CUG252, 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.
CUG252Drug
CUG252 will be administered by subcutaneous injection.
PlaceboDrug
Placebo will be administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| CUG252 | Experimental | CUG252 or placebo will be administered to participants in a 3:1 ratio. Receives: Drug: CUG252 |
| Placebo | Placebo comparator | CUG252 or placebo will be administered to participants in a 3:1 ratio. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with Treatment Emergent Adverse Events
To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.
Measured: Up to 64 Days
Secondary outcomes (6)
Pharmacokinetics profile of CUG252 (AUC)
To assess the Area under the plasma concentration versus time curve (AUC)
Measured: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (Cmax)
To assess the maximum plasma concentration (Cmax)
Measured: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (Tmax)
To assess the time of maximum concentration (Tmax)
Measured: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (t1/2)
To assess the half-life (t1/2)
Measured: Day 1 pre dose through Day 64
Immunogenicity of CUG252
To measure the serum concentration of antibodies against CUG252
Measured: Day 1 pre dose through Day 64
Change in the number and percentages of immune cells
To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.
Measured: Day 1 pre dose through Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start24 Apr 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cugene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866861
- Sponsor's protocol ID
- CUG252-P102
- Status last verified
- May 2025
- First submitted
- 20 Mar 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following Multiple Dose Administrations in Participants With Mild-to-Moderate SLE
- ClinicalTrials.gov ID
- NCT05866861
- Acronym / sponsor ID
- CUG252-P102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cugene Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 19 May 2023 (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 main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
Detailed description
CUG252 is a potential best-in-class engineered IL-2 compound, designed to have improved Treg selectivity while reducing undesired IL-2 activity.
This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunologic effects of CUG252 following subcutaneous administration of multiple ascending doses in participants with mild-to-moderate SLE. The effects of SLE disease activity and biomarkers will also be evaluated.. The SLE participants will receive randomized multiple subcutaneous doses of CUG252 or placebo. After receiving the last dose of CUG252 or placebo, participants will be followed to study day 64 post first dose administration to evaluate safety, PK, PD and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CUG252 | Experimental | Drug: CUG252CUG252 or placebo will be administered to participants in a 3:1 ratio. |
| Placebo | Placebo comparator | Drug: PlaceboCUG252 or placebo will be administered to participants in a 3:1 ratio. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participant, aged 18 to 65 years (inclusive), at time of consent
- BMI greater than or equal to 18 and less than 39 kg/m2 at Screening
- Diagnosis of SLE at least 6 months prior to Screening
- Minimal to moderate SLE disease activity
- If a participant is taking oral prednisone, the dose must be less than or equal to 20 mg/day for a minimum of 8 weeks prior to Screening and at a stable dose for a minimum of 2 weeks prior to Screening
Key exclusion criteria (2 listed)
- Have one or more of the following medical conditions: SARS-CoV-2 infection 30 days prior to drug administration, evidence of Grade 3 or greater hematologic, hepatic, or rental dysfunction, active severe or unstable neuropsychiatric SLE, active severe renal disease, history of severe active lupus nephritis with proteinuria levels greater than 1.0 g/24 hours, or dialysis in the last 6 months. History of current diagnosis of other autoimmune/inflammatory diseases, history of any non-SLE disease that has required treatment with corticosteroids for more than 2 weeks within the last 12 weeks prior to Screening, active clinically significant bacterial, viral, or fungal infection at Screening, active or latent TB at Screening, pulmonary infection or active lung disease besides those related to lupus, or severe pulmonary disease requiring oxygen therapy. History of condition that predisposes participant to infection, confirmed positive serology at Screening, history of opportunistic infection requiring hospitalization or IV antimicrobial treatment within the last year, history of organ or hematopoietic stem cell transplant, history of major surgery within 12 weeks of Screening, history of significant cardiovascular disease, history of gastrointestinal bleeding, history of cancer apart from successfully treated squamous or basal cell carcinoma or cervical cancer in situ.
- Are on one or more of the following medications: have received vaccination within 30 days prior to Screening (including COVID-19 vaccination), Aldesleukin or other IL-2 derivatives at any time, T cell depleting agents and inhibitors of T cell activation at any time, Anti-BLyS/BAFF inhibitors, IL-1 receptor antagonist, anti-TNF therapy, and anti-interferon alpha receptor inhibitor within 3 months prior to Screening, rituximab or other B-cell depleting agent within 6 months, glucocorticoids within 6 weeks prior to Day 1, other immunosuppressant drugs within 8 weeks, history of cytotoxic medications within 12 months, receipt of blood products within 6 months, plasmapheresis within 30 days of Screening.
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 |
|---|---|---|
| CUG252CUG252 will be administered by subcutaneous injection. | Drug | CUG252 |
| PlaceboPlacebo will be administered by subcutaneous injection. | Drug | Placebo |
Primary outcome
Number and percentage of subjects with Treatment Emergent Adverse Events
Time frame: Up to 64 Days
To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.
6 secondary outcomes
Pharmacokinetics profile of CUG252 (AUC)
Time frame: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (Cmax)
Time frame: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (Tmax)
Time frame: Day 1 pre dose through Day 64
Pharmacokinetics profile of CUG252 (t1/2)
Time frame: Day 1 pre dose through Day 64
Immunogenicity of CUG252
Time frame: Day 1 pre dose through Day 64
Change in the number and percentages of immune cells
Time frame: Day 1 pre dose through Day 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Related trials for Systemic Lupus Erythematosus
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CUG252 in people with Systemic Lupus Erythematosus and SLE (Systemic Lupus), run by Cugene Inc. at 11 sites in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 24 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 11 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of subjects with Treatment Emergent Adverse Events (time frame: Up to 64 Days). 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 Jun 2026.