A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus

• Sponsor: Cugene Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05866861
• Collaborator: (none)
• Enrollment: 40
• Locations: 11
• Arms: 2
• Anticipated Duration (Months): 14.3
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus; SLE (Systemic Lupus); Autoimmune	Drug: CUG252; Drug: Placebo	Phase 1

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

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 24, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CUG252 CUG252 or placebo will be administered to participants in a 3:1 ratio.	Drug: CUG252; CUG252 will be administered by subcutaneous injection.
Placebo Comparator: Placebo CUG252 or placebo will be administered to participants in a 3:1 ratio.	Drug: Placebo; Placebo will be administered by subcutaneous injection.

Outcome Measures

Primary Outcome Measures

1. Number and percentage of subjects with Treatment Emergent Adverse Events [Up to 64 Days]

   To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.

Secondary Outcome Measures

1. Pharmacokinetics profile of CUG252 (AUC) [Day 1 pre dose through Day 64]

   To assess the Area under the plasma concentration versus time curve (AUC)

2. Pharmacokinetics profile of CUG252 (Cmax) [Day 1 pre dose through Day 64]

   To assess the maximum plasma concentration (Cmax)

3. Pharmacokinetics profile of CUG252 (Tmax) [Day 1 pre dose through Day 64]

   To assess the time of maximum concentration (Tmax)

4. Pharmacokinetics profile of CUG252 (t1/2) [Day 1 pre dose through Day 64]

   To assess the half-life (t1/2)

5. Immunogenicity of CUG252 [Day 1 pre dose through Day 64]

   To measure the serum concentration of antibodies against CUG252

6. Change in the number and percentages of immune cells [Day 1 pre dose through Day 64]

   To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 1001	Anniston	Alabama	United States	36207
2	Site 1011	La Jolla	California	United States	92037
3	Site 1002	Clearwater	Florida	United States	33765
4	Site 1009	Tampa	Florida	United States	33606
5	Site 1007	Lawrenceville	Georgia	United States	30046
6	Site 1010	Columbus	Ohio	United States	44106
7	Site 1005	Middleburg Heights	Ohio	United States	44130
8	Site 1003	Duncansville	Pennsylvania	United States	16635
9	Site 1006	Dallas	Texas	United States	75231
10	Site 1004	Mesquite	Texas	United States	75150
11	Site 1012	Seattle	Washington	United States	98195

Sponsors and Collaborators

• Cugene Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cugene Inc.
• ClinicalTrials.gov Identifier: NCT05866861
• Other Study ID Numbers: CUG252-P102
• First Posted: May 19, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

No Results Posted as of May 19, 2023