TELITACICEPT for Systemic lupus erythematosus (moderately to severely active)

Inclusion criteria

• {"criterion_text":"- Adult patients (18-70 years old) who are able to understand and willing to sign the ICF and comply with study procedures as defined in the protocol. Adolescent patients (12-17 years old) who are able to sign an age-appropriate assent with a legal guardian who can understand and voluntarily sign an informed consent."}
• {"criterion_text":"- Currently receiving at least one of the following SoC SLE therapies: a. Oral GCs, if taken, the following criteria must be met: i. Must have been on an average daily dose of ≤20 mg/day prednisone or equivalent for ≥2 weeks prior to screening. ii. Must have been on a stable dose of oral GCs for ≥4 weeks prior to Day 0 (first dose of study medication). No dose adjustment during screening period is permitted. iii. If the oral GC is the only SoC therapy (i.e., the patient is not concurrently receiving any antimalarial or immunosuppressant), a dose of >7.5 mg/day but ≤ 20 mg/day of prednisone or equivalent is required. b. Antimalarial (≤250mg/day chloroquine, ≤400mg/day hydroxychloroquine): administered for a minimum of 12 weeks before screening and at a stable dose for ≥6 weeks prior to Day 0 (first dose of study medication). c. Immunosuppressants: administered for a minimum of 12 weeks before screening and at a stable dose for at least 6 weeks prior to Day 0 (first dose of study medication). The allowable immunosuppressants (no more than 1) and maximum allowable dosages are included below: o azathioprine (oral) ≤ 200 mg/day or 6 mercaptopurine ≤ 100 mg/day o mizoribine (oral) ≤ 150 mg/day o methotrexate (oral, subcutaneous, or IM) ≤ 25 mg/week o mycophenolate mofetil (oral) ≤ 2 grams/day or mycophenolic acid (oral) ≤ 1.44 grams/day o leflunomide (oral) ≤ 20 mg/day o tacrolimus (oral) ≤ 5 mg/day in divided doses o voclosporin (oral) ≤ 47.4 mg/day in divided doses o cyclosporine (oral) ≤ 4 mg/kg/day in divided doses d. If an immunosuppressant or antimalarial agent is discontinued prior to screening, the last dose must be at least 4 weeks prior to screening."}
• {"criterion_text":"- Women of childbearing potential (WOCBP) must use highly effective methods of contraception (Refer to Appendix 10.4.2) throughout their study participation and for at least 4 months following the last administration of the study medication. For all WOCBP patients, a negative serum pregnancy test must be documented at screening. In addition, a negative urine (dipstick) pregnancy test must be documented at baseline (Day 0) prior to the first dose of the study medication. [For purposes of this study, ‘non-childbearing’ potential is defined as a premenarcheal female who has not yet entered puberty as evidenced by lack of breast development (palpable glandular breast tissue); or any female who has undergone a hysterectomy, S/P bilateral oophorectomy or tubal ligation, or is post-menopausal.] Female refers to the gender assigned at birth."}
• {"criterion_text":"- Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to adhere to the same effective birth control methods, from Day 0 through at least 4 months after receipt of the final dose of the study medication."}
• {"criterion_text":"- All patients must agree to abstain from donating blood, sperm or eggs while on the study medication and at least 4 months after the last dose."}
• {"criterion_text":"- Appropriately vaccinated (e.g., vaccinations for pneumococcus, influenza, and COVID-19) per investigator’s clinical judgment considering patient’s risk factors and according to country and local guidelines."}
• {"criterion_text":"- Age 12-70 years at screening. a. Enrolling subjects under the age of 18 is optional and only applicable for sites that have EC approval. b. Subjects under the age of 18 will not be included in the primary analysis."}
• {"criterion_text":"- Weight ≥35 kg at screening and at Day 0."}
• {"criterion_text":"- Has had a diagnosis of SLE for at least 6 months prior to the Screening Visit."}
• {"criterion_text":"- Meets the 2019 EULAR/ACR Classification criteria for SLE."}
• {"criterion_text":"- Meets qualification standards as assessed by a CRC which include: a. Convincing diagnosis of SLE. b. Evidence of acute SLE disease that justifies the scoring on disease activity instruments and entry into a clinical trial of an investigational drug. c. Sufficient medical stability to enter the protocol without undue risk."}
• {"criterion_text":"- Moderate to severely active SLE is defined by the following: a. SELENA-SLEDAI total score ≥ 6 points with clinical SLEDAI score ≥4 points (excluding points attributed to CNS manifestations) at screening. i. The clinical SLEDAI is the score without the inclusion of points attributable to any laboratory results (i.e., hematology, renal or immunologic measures) b. BILAG-2004 organ system scores of at least 1A or 2 B at screening."}
• {"criterion_text":"- Clinical SLEDAI score of ≥ 4 at Day 0 prior to randomization (excluding points attributed to CNS manifestations) and no “definite” improvement or “major or complete” improvement in SLE disease activity during screening period based on Clinician’s Global Impression of Change (CGIC)."}
• {"criterion_text":"- Positive ANA ≥1:160 by immunofluorescent assay at the central laboratory, and/or positive anti-dsDNA antibodies, and/or positive anti-Sm antibodies. If a patient tests negative for ANA, anti-dsDNA, and anti-Sm antibodies, but positive for other autoantibodies (e.g., anti-SSA/Ro antibodies) or low complements, the eligibility will be reviewed and determined by the CRC based on the patient’s disease activity and other relevant criteria. All tests are required to be evaluated at the central laboratory and borderline results are considered negative. The serological parameter testing may be repeated once at the central laboratory during the screening period for consideration of eligibility."}

Exclusion criteria

• {"criterion_text":"- Active lupus nephritis undergoing induction therapy or unstable renal diseases (e.g., levels of proteinuria, serum creatinine or active urinary sediment consistent with active nephritis that cannot be confirmed to be stable) within 12 weeks prior to screening, that in the opinion of the investigator or the CRC the patient would be unsuitable to enter a placebo controlled clinical trial."}
• {"criterion_text":"- Active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizure, psychosis or acute confusional state, cerebrovascular accident, demyelination syndrome, cranial neuropathy, or evidence of active central nervous system vasculitis within 12 weeks of the screening visit."}
• {"criterion_text":"- Have a primary diagnosis of a different autoimmune or inflammatory disorder that, in the opinion of the investigator or CRC, could confound SLE disease activity measures. Examples might include psoriasis, psoriatic arthritis, Lyme disease or multiple sclerosis."}
• {"criterion_text":"- History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening. Patients with history of antiphospholipid syndrome who have had no thromboembolic event for at least 12 months and are on stable doses of therapeutic anticoagulation for at least one month prior to screening may be qualified at the discretion of the CRC. History of positive antiphospholipid antibodies with no associated clinical events is allowed."}
• {"criterion_text":"- History of any non-SLE disease that has required treatment with oral or parenteral GCs for more than a total of 2 weeks within the last 24 weeks prior to screening."}

Primary endpoints

• {"endpoint_text":"- The proportion of patients achieving an SLE Responder Index (SRI-4) response at Week 52.","definition_or_measurement_approach":"SRI-4 response assessed at Week 52 using the SLE Responder Index (SRI-4) criteria (proportion of patients meeting SRI-4 at Week 52)."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients achieving an SRI-4 response at Week 24.","definition_or_measurement_approach":"SRI-4 response assessed at Week 24 (proportion of patients meeting SRI-4 at Week 24)."}
• {"endpoint_text":"- Among patients who were on an average daily dose of >7.5 mg/day prednisone or equivalent at baseline, the proportion of those patients achieving a GC dose reduction of ≥25% from baseline to ≤7.5 mg/day prednisone or equivalent by Week 40 and maintaining that dose through Week 52.","definition_or_measurement_approach":"Proportion achieving specified glucocorticoid (GC) dose reduction target by Week 40 and maintained through Week 52 among baseline >7.5 mg/day prednisone-equivalent users."}
• {"endpoint_text":"- The proportion of patients achieving an SRI-4 response at Week 52, while maintaining an average daily dose of ≤7.5 prednisone or equivalent between Week 40 and Week 52.","definition_or_measurement_approach":"Proportion meeting SRI-4 at Week 52 with concurrent maintenance of average daily prednisone (or equivalent) ≤7.5 mg between Weeks 40–52."}
• {"endpoint_text":"- The proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52.","definition_or_measurement_approach":"BICLA response assessed at Week 52 (proportion of patients meeting BICLA criteria)."}
• {"endpoint_text":"- Time to flare assessed by SFI from baseline through Week 52.","definition_or_measurement_approach":"Time-to-event analysis for SLE flare using SFI from baseline through Week 52."}
• {"endpoint_text":"- The proportion of patients achieving clinically meaningful improvement in the FACIT-F at Week 52.","definition_or_measurement_approach":"Proportion of patients meeting predefined clinically meaningful improvement thresholds on the FACIT-F fatigue scale at Week 52."}
• {"endpoint_text":"- o\tIncidence of AE, SAEs, and AESI. o\tAEs that lead to patient discontinuation of study medication. o\tChange from baseline in vital sign parameters by visit. o\tChange from baseline in clinical laboratory assessments by visit.","definition_or_measurement_approach":"Safety endpoints include incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), AEs causing discontinuation, and changes from baseline in vital signs and laboratory parameters by visit."}

Croatia

Earliest CTIS Part Ii Submission Date

29-11-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

53

Number Of Sites

1

Number Of Participants

9

France

Earliest CTIS Part Ii Submission Date

25-10-2024

Latest Decision Or Authorization Date

17-01-2025

Processing Time Days

84

Number Of Sites

1

Number Of Participants

9

Greece

Earliest CTIS Part Ii Submission Date

21-11-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

61

Number Of Sites

2

Number Of Participants

9

Romania

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

120

Number Of Sites

2

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

05-12-2024

Latest Decision Or Authorization Date

21-01-2025

Processing Time Days

47

Number Of Sites

1

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

20-01-2025

Processing Time Days

119

Number Of Sites

1

Number Of Participants

9

Primary sponsor

Full Name

Remegen Co. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

China

Contract research organisations

Name

Suvoda LLC

Responsibilities

sponsorDuties codes: 3

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: 7

Name

IQVIA RDS Hellas Single Member S.A.

Responsibilities

sponsorDuties codes: 1,12,2

Name

IQVIA Limited

Responsibilities

sponsorDuties codes: 1,12,2,4,5

Name

Cerba

Responsibilities

sponsorDuties codes: 4

Name

Eresearchtechnology Inc.

Responsibilities

sponsorDuties codes: 15 (eCOA)

Third parties

• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12,2","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Cerba","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,12,2,4,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 15 (eCOA)","organisation_type":"Pharmaceutical company"}