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Status:

NO_LONGER_AVAILABLE

Anifrolumab Early Access Program

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Clinigen, Inc.

Conditions:

Systemic Lupus Erythematosus

Eligibility:

All Genders

18+ years

Brief Summary

To provide early access (ie, before marketing authorisation) to anifrolumab 300 mg IV Q4W while receiving standard therapy in adult patients with moderate-to-severe active SLE

Detailed Description

This is a multi-centre, open-label, early access program (EAP) designed to provide treatment access to intravenous (IV) treatment regimen of 300 mg anifrolumab (MEDI-546) every 4 weeks (Q4W) for eligi...

Eligibility Criteria

Inclusion

  • Population A:
  • Received anifrolumab or placebo in the long-term extension study, D3461C00009, and are within 12 weeks of Week 164 (follow-up visit 2).
  • Provided written informed consent before any program-related procedures are performed.
  • Adequate peripheral venous access.
  • Females of childbearing potential must use two effective methods of avoiding pregnancy, only one of which is a barrier method, from screening until 12 weeks after final dose of anifrolumab, unless the patient is surgically sterile (eg, bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year ostmenopausal, or practises sustained abstinence consistent with the patient's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the patient has an elevated follicle-stimulating hormone (FSH) level greater than the local laboratory value of post-menopausal at screening - as detailed in Section 5.4.3.
  • All males (sterilised or non-sterilised) who are sexually active must use a condom (with spermicide where commercially available) from Day 1 (first dose of anifrolumab) until at least 12 weeks after receiving the final dose of anifrolumab. It is strongly recommended that the female partner of a male patient also uses an effective method of contraception (other than a barrier method) throughout this period. Male patients must not donate sperm while taking part in the EAP and for 12 weeks after their last dose of anifrolumab - see Section 5.4.3 for further details.
  • Females with an intact cervix must have a documented normal Pap smear without documented malignancy (eg, no signs of cervical intraepithelial neoplasia \[CIN\] grade III, carcinoma in situ \[CIS\] or adenocarcinoma in situ \[AIS\]) within 2 years of entering this EAP and receiving anifrolumab. Any abnormal Pap smear result documented within 2 years before receiving anifrolumab must be repeated to confirm patient eligibility.
  • COVID-19: Any negative polymerase chain reaction (PCR) test result (central laboratory) at screening and no known or suspected COVID-19 exposure within 2 weeks prior to screening. If there is a known or suspected exposure, a patient must be negative upon retest obtained after 2 weeks and must remain asymptomatic for inclusion in the study. Note: Patients positive at screening may be re-screened after 3 months provided there has been no development of severe COVID-19 disease or sequalae.

Exclusion

  • Discontinued anifrolumab or placebo, for any reason including an AE, before completing Year 3 of the treatment period for study 09 or study 1145.
  • Major medical event, such as cerebrovascular accident (CVA), myocardial infarction (MI), malignancy, opportunistic infection, suicide attempt, or that, in the opinion of the Treating Physician, would interfere with patient safety.
  • Any other condition that, in the opinion of the Treating Physician, would interfere with patient safety.
  • Active severe or unstable neuropsychiatric SLE where, in the opinion of the Treating Physician, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
  • Active severe SLE-driven renal disease where, in the opinion of the Treating. Physician or delegate, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
  • Is receiving any of the following medications:
  • Azathioprine \> 200 mg/day
  • Mycophenolate mofetil \> 2 g/day or mycophenolic acid \> 1.44 g/day
  • Oral, subcutaneous (SC), or intramuscular (IM) methotrexate \> 25 mg/week
  • Oral prednisone \> 40 mg/day (or prednisone equivalent - see Appendix E1)
  • Mizoribine \> 150 mg/day
  • Biologics eg, belimumab, rituximab
  • Received any of the following:
  • Live or attenuated vaccine within 8 weeks before signing the ICF. Note: administration of inactivated vaccines is acceptable - the Sponsor recommends that Treating Physicians ensure all patients are up to date on required vaccinations, including influenza (inactivated/recombinant) before EAP entry.
  • Restricted medications listed in Appendix D if the washout period is not met.
  • Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives (whichever is greater) before signing the ICF (see Appendix D).
  • Received any commercially available biologic agent within 5 half-lives before signing ICF (see Appendix D).
  • Received B-cell-depleting therapy (including, but not limited to: ocrelizumab, ofatumumab, atacicept, obinutuzumab, rituximab) within 26 weeks before signing the ICF; within 40 weeks for atacicept (see Appendix D) or if therapy was administered 26 weeks or more ago (40 weeks for atacicept), absolute B-cell count should not be less than the lower limit of normal (LLN) or baseline (whichever is lower) before receipt of B-cell-depleting therapy.
  • Positive hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
  • Known history of allergy or reaction to any component of anifrolumab or history of anaphylaxis to any human gamma globulin therapy.
  • COVID-19: Any history of severe COVID-19 infection (e.g. requiring hospitalisation, intensive care unit (ICU) care or assisted ventilation) or any prior COVID-19 infection with unresolved sequelae. Any acute COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms) within the last 3 months prior to screening.
  • Population B:
  • Inclusion criteria:
  • Patients who have:
  • Completed study D3461C0009 safety follow-up period (Week 164), and more than 12 weeks since Week 164 (safety follow-up visit 2); OR
  • Completed safety follow-up period in phase 2 study CD1145; OR
  • Not previously taken part in any anifrolumab clinical study and have attempted the standard therapeutic options at the maximum tolerated dose (see inclusion criterion 2); AND
  • i. Are not eligible for enrollment in an anifrolumab clinical study, AND ii. Have moderate to severe SLE (no lupus nephritis or severe CNS lupus)
  • Attempted standard therapies, such as an antimalarial, therapeutic doses of oral corticosteroids, minimum of 2 immunosuppressants and biologics (belimumab or rituximab, if available in their country) from the following therapeutic options at the maximum tolerated dose:
  • Azathioprine ≤ 200 mg/day
  • Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine)
  • Mycophenolate mofetil ≤ 2 g/day or mycophenolic acid ≤ 1.44 g/day
  • Oral, SC, or IM methotrexate ≤ 25 mg/week
  • Mizoribine ≤ 150 mg/day (Japan only)
  • Oral prednisone or equivalent (see Appendix E1) ≤ 40 mg/day
  • Biologics (eg, belimumab, rituximab).
  • Provided written informed consent before any program-related procedures are performed.
  • Adequate peripheral venous access.
  • Females of childbearing potential must use two effective methods of avoiding pregnancy, only one of which is a barrier method, from screening until 12 weeks after final dose of anifrolumab, unless the patient is surgically sterile (eg, bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1-year postmenopausal, or practises sustained abstinence consistent with the patient's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the patient has an elevated FSH level greater than the local laboratory value of postmenopausal at screening - as detailed in Section 5.4.3.
  • All males (sterilised or non-sterilised) who are sexually active must use a condom (with spermicide where commercially available) from Day 1 (first dose of anifrolumab) until at least 12 weeks after receiving the final dose of anifrolumab. It is strongly recommended that the female partner of a male patient also uses an effective method of contraception (see Section 5.4.3) (other than a barrier method) throughout this period. Male patients must not donate sperm while taking part in the EAP and for 12 weeks after their last dose of anifrolumab - see Section 5.4.3 for further details.
  • Females with an intact cervix must have a documented normal Pap smear without documented malignancy (eg, no signs of CIN grade III, CIS or AIS) within 2 years of entering this EAP and receiving anifrolumab. Any abnormal Pap smear result documented within 2 years before receiving anifrolumb must be repeated to confirm patient eligibility.
  • COVID-19: Any negative PCR test result (central laboratory) at screening and no known or suspected COVID-19 exposure within 2 weeks prior to screening. If there is a known or suspected exposure, a patient must be negative upon retest obtained after 2 weeks and must remain asymptomatic for inclusion in the program. Note: Patients positive at screening may be re-screened after 3 months provided there has been no development of severe COVID-19 disease or sequalae.
  • Exclusion criteria:
  • Discontinued anifrolumab or placebo before completing Year 3 of the treatment period for study D3461C0009 or study CD1145.
  • Major medical event, such as CVA, MI, malignancy, opportunistic infection, suicide attempt, or that, in the opinion of the Treating Physician, would interfere with patient safety.
  • Any condition that, in the opinion of the Treating Physician, would interfere with patient safety.
  • Active severe or unstable neuropsychiatric SLE where, in the opinion of the Treating Physician, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
  • Active severe SLE-driven renal disease where, in the opinion of the Treating Physician or delegate, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.
  • Is receiving any of the following medications:
  • Azathioprine \> 200 mg/day
  • Mycophenolate mofetil \> 2 g/day or mycophenolic acid \> 1.44 g/day
  • Oral, SC, or IM methotrexate \> 25 mg/week
  • Oral prednisone \> 40 mg/day (or prednisone equivalent - see Appendix E1)
  • Mizoribine \> 150 mg/day
  • Biologics eg, belimumab, rituximab
  • Received any of the following:
  • Live or attenuated vaccine within 8 weeks before signing the ICF. Note: administration of inactivated vaccines is acceptable - the Sponsor recommends that Treating Physicians ensure all patients are up to date on required vaccinations, including influenza (inactivated/recombinant) before EAP entry.
  • Restricted medications listed in Appendix D if the washout period is not met.
  • Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives (whichever is greater) before signing the ICF (see Appendix D).
  • Received any commercially available biologic agent within 5 half-lives before signing ICF (see Appendix D).
  • Received B-cell-depleting therapy (including, but not limited to: ocrelizumab, ofatumumab, atacicept, obinutuzumab, rituximab) within 26 weeks before signing the ICF; within 40 weeks for atacicept (see Appendix D) or if therapy was administered 26 weeks or more ago (40 weeks for atacicept), absolute B-cell count should not be less than the LLN or baseline (whichever is lower) before receipt of B-cell-depleting therapy.
  • Positive hepatitis B, hepatitis C or HIV.
  • Known history of allergy or reaction to any component of anifrolumab or history of anaphylaxis to any human gamma globulin therapy.
  • COVID-19: Any history of severe COVID-19 infection (e.g. requiring hospitalisation, ICU care or assisted ventilation) or any prior COVID-19 infection with unresolved sequelae. Any acute COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms) within the last 3 months prior to screening.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04750057

Last Update

May 6 2021

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