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

Primary Purpose

Systemic Lupus Erythematosus, SLE (Systemic Lupus), Autoimmune

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CUG252
Placebo
Sponsored by
Cugene Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 1001Recruiting
  • Site 1011
  • Site 1002
  • Site 1009
  • Site 1007
  • Site 1010
  • Site 1005Recruiting
  • Site 1003Recruiting
  • Site 1006
  • Site 1004Recruiting
  • Site 1012

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CUG252

Placebo

Arm Description

CUG252 or placebo will be administered to participants in a 3:1 ratio.

CUG252 or placebo will be administered to participants in a 3:1 ratio.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pharmacokinetics profile of CUG252 (AUC)
To assess the Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics profile of CUG252 (Cmax)
To assess the maximum plasma concentration (Cmax)
Pharmacokinetics profile of CUG252 (Tmax)
To assess the time of maximum concentration (Tmax)
Pharmacokinetics profile of CUG252 (t1/2)
To assess the half-life (t1/2)
Immunogenicity of CUG252
To measure the serum concentration of antibodies against CUG252
Change in the number and percentages of immune cells
To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.

Full Information

First Posted
March 20, 2023
Last Updated
May 10, 2023
Sponsor
Cugene Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05866861
Brief Title
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cugene Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, SLE (Systemic Lupus), Autoimmune

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CUG252
Arm Type
Experimental
Arm Description
CUG252 or placebo will be administered to participants in a 3:1 ratio.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
CUG252 or placebo will be administered to participants in a 3:1 ratio.
Intervention Type
Drug
Intervention Name(s)
CUG252
Intervention Description
CUG252 will be administered by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by subcutaneous injection.
Primary Outcome Measure Information:
Title
Number and percentage of subjects with Treatment Emergent Adverse Events
Description
To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.
Time Frame
Up to 64 Days
Secondary Outcome Measure Information:
Title
Pharmacokinetics profile of CUG252 (AUC)
Description
To assess the Area under the plasma concentration versus time curve (AUC)
Time Frame
Day 1 pre dose through Day 64
Title
Pharmacokinetics profile of CUG252 (Cmax)
Description
To assess the maximum plasma concentration (Cmax)
Time Frame
Day 1 pre dose through Day 64
Title
Pharmacokinetics profile of CUG252 (Tmax)
Description
To assess the time of maximum concentration (Tmax)
Time Frame
Day 1 pre dose through Day 64
Title
Pharmacokinetics profile of CUG252 (t1/2)
Description
To assess the half-life (t1/2)
Time Frame
Day 1 pre dose through Day 64
Title
Immunogenicity of CUG252
Description
To measure the serum concentration of antibodies against CUG252
Time Frame
Day 1 pre dose through Day 64
Title
Change in the number and percentages of immune cells
Description
To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.
Time Frame
Day 1 pre dose through Day 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cugene, Inc.
Phone
781-893-5800
Email
info@cugene.com
Facility Information:
Facility Name
Site 1001
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 1011
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 1002
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 1009
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 1007
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 1010
City
Columbus
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 1005
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 1003
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 1006
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Site 1004
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 1012
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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