Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Daxdilimab
Product Code: HZN-7734, VIB7734
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daxdilimab
CAS Number: 2245966-28-1
Current Sponsor code: HZN-7734
Other desc
Sponsors
Horizon Therapeutics Ireland DAC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to understand and provide written informed consent prior to any study-related procedures and to comply with all study requirements and complete study assessments. 2. Must have qualified for and received IP (daxdilimab or placebo) and complete the treatment period (through Day 337) in the RECAST SLE study. Subjects who discontinued early from IP in RECAST SLE are not eligible for this study. 3. Women of childbearing potential must have a negative urine pregnancy test on Day 1. Women of childbearing potential are defined as those who are not surgically sterile (ie, surgical sterilization includes bilateral salpingectomy, bilateral oophorectomy, or hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause and a follicle-stimulating hormone [FSH] within the postmenopausal range as established by the central laboratory during the screening period of the RECAST SLE study, unless on postmenopausal hormone replacement therapy).If a female subject becomes postmenopausal during the study (ie, 12months with no menses without an alternative medical cause, unless on postmenopausal hormone replacement therapy), a FSH test will be performed at the central laboratory. If the FSH level is within the postmenopausal range, the female subject will not be required to use contraception after that. Women of childbearing potential who are sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of the ICF and must agree to continue using such precautions through the end of the study follow-up or 3months (approximately 5 half-lives) following the last dose of IP in the case of early withdrawal from the study, and refrain from egg retrieval/egg donation during this period. After this point, a decision about contraception should be made by the subject and her regular healthcare providers. Female subjects who participate in the SLE OLE are expected to maintain the same form of contraception they used during the RECAST SLE study. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Note that because mycophenolate affects the metabolism of hormonal contraceptives and may reduce their effectiveness in women receiving MMF or mycophenolic acid (MPA) who are using hormonal contraceptives for birth control, the subject must employ an additional contraceptive method (eg, barrier method). 4. Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose. Because a male condom with spermicide is not a highly effective contraception method, it is strongly recommended that male subjects advise their women partners of childbearing potential to use a highly effective method of contraception throughout this period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 148 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration. 2. Participation in another clinical study with an IP during the RECAST SLE study period. 3. Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety. 4. Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1. 5. Clinically significant active infection at Visit1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication (chronic nail infections are allowed). 6. Pregnant or lactating females. 7. Receipt of any prohibited medication during the RECAST SLE study period. Receipt of any restricted medications during the RECAST SLE study period must be discussed with the Sponsor’s Medical Monitor and agreed upon prior to enrollment into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of 200mg Q12W daxdilimab;Secondary Objective: To characterize the PK, PD, and immunogenicity of daxdilimab;Primary end point(s): Incidence of AEs, SAEs, and AESIs;Timepoint(s) of evaluation of this end point: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Daxdilimab concentrations, change in pDCs, and ADA rate;Timepoint(s) of evaluation of this end point: Week 0, Week 12, Week 24, Week 36, Week 48, Week 56 | — |
Countries
Argentina, Greece, India, Mexico, Poland, Serbia, Spain, Taiwan, United States
Contacts
Public ContactCourtney Sauer
PPD
Outcome results
None listed