A study of anifrolumab in children and adolescents (5 to < 18 years old) with moderate to severe lupus to find the appropriate anifrolumab dose for those participants and to confirm anifrolumab is safe and works in this populatio
- Conditions
- Moderate to Severe Active Systemic Lupus ErythematosusMedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-502289-25-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Participant’s parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation., At Screening, body weight = 15 kg, Male participants: All fertile males who are sexually active must use a condom from Day 1 until at least 16 weeks after receipt of the last dose of study intervention. Tanner staging (Section 1.3 and Section 8.3.3) is required to allow the investigator to assess when male participants may achieve potential fertility (ie, Tanner stage 3 and above) NOTE: It is strongly recommended that the female partner of a male participant also use an effective method of contraception from Table 10 throughout this period., Female participants of childbearing potential* must meet all the following requirements: (a)Must have negative serum ß-human chorionic gonadotropin test result at Screening. (b)Must have negative urine pregnancy test result prior to randomization and administration of study intervention (DAY 1) (c)If sexually active, must use one highly effective method of contraception, plus a male condom, from Screening until 16 weeks after the last dose of study intervention (Table 10). Participants who are not sexually active, ie, true sexual abstinence in line with the preferred and usual lifestyle choice of the participant, are not required to use contraception. *A female is considered of childbearing potential if she is capable of conceiving. While this is typically the case following first menarche, adolescents can ovulate prior to first menarche. Examination of adolescents for the development of secondary sexual characteristics (Tanner stage) is useful for judging possible fertility. Assessment of female participants (Tanner staging – Sections 1.3 and 8.3.3 and Appendix P) for the development of secondary sexual characteristics, is mandatory during Screening and should be used by the investigator along with assessment of menarcheal status, for judging potential fertility. Female participants will be considered of childbearing potential if they have had first menarche or achieved Tanner stage 3 or higher. Highly effective methods of contraception (those that can achieve a failure rate of less than 1% per year when used consistently and correctly) include those listed in Table 10., At Screening, negative SARS-CoV-2 RT-PCR or rapid antigen test result (central or local laboratory, as appropriate) and no known or suspected COVID-19 infection or exposure within 2 weeks prior to Screening based on the COVID-19 Questionnaire (Appendix Q): (a)If suspected infection or known/suspected exposure: Negative retest result obtained after a minimum of 2 weeks from first test and participant remaining asymptomatic without new exposure NOTE: If positive RT-PCR or rapid antigen test result at Screening: Rescreening may be allowed after 6 weeks of mild/asymptomatic infections or at the discretion of the investigator, provided there has been no development of severe COVID-19 infection or sequelae. Participants may also be rescreened a second time following rescreening procedures, if the reason for screen failure was due to positive COVID-19 test, Completion of Screening procedures within 30 days after signing the ICF., At the time of signing th
Known diagnosis of an IFN-mediated autoinflammatory interferonopathy (eg, AG, SAVI, CANDLE, COPA)., For females of childbearing potential: Currently lactating, breastfeeding, pregnant (confirmed with a positive serum pregnancy test) or intending to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following the last dose of study intervention., Spontaneous or induced abortion, still or live birth, or pregnancy = 4 weeks prior to signing the ICF., COVID-19: (a)Any history of severe COVID-19 infection (eg, requiring prolonged hospitalization [hospitalization for observational purposes is not exclusionary], intensive care unit care, or assisted ventilation) or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae. (b)Within 6 weeks prior to signing the ICF, any mild/asymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms)., History of or current alcohol, drug, or chemical abuse prior to signing the ICF., Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period., Active hepatitis B infection, as per central laboratory, defined as: (a)Positive HBsAg; or (b)Positive HBcAb and HBV DNA detected above the lower limit of quantification by reflex testing by the central laboratory. NOTE: Participants who are HBcAb positive at Screening will be tested every 3 months for HBV DNA. To remain eligible for the study, the participant’s HBV DNA levels must remain below the LLOQ as per the central laboratory., Active severe or unstable neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex., Active severe uncontrolled SLE-driven nephritis defined as a significant renal disease , as determined by the Principal Investigator. NOTE: Participants with clinically stable lupus nephritis which can be managed with permitted medications (Table 12 and Table 13) are not excluded., History of, or current diagnosis of, catastrophic APS within one year prior to signing the ICF. Participants with other degrees of APS adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited to the study., History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF., Receipt of any live or attenuated vaccine within 8 weeks prior to signing the ICF: (a)Administration of killed, inactivated, or recombinant vaccines is acceptable (b)AstraZeneca recommends investigators ensure all participants are up to date on required/recommended vaccinations including influenza (inactivated/recombinant) vaccine prior to study entry) (Section 6.9.5)., Any other significant disease, disorder, or finding that, in the opinion of the investigator or AstraZeneca, may significantly increase the risk to the participant because of participation in the study, affect their ability to participate in the study, or interfere with the evaluation of study intervention and/or interpretation of the participant’s safety and the study data., History of re
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method