Anifrolumab Early Access Program

NCT04750057 | Unknown

• 1 other identifier: D3461R00027
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Systemic Lupus Erythematosus

Interventions

Anifrolumab DRUG

Multi-centre, open-label, early access program (EAP) designed to provide access to intravenous (IV) treatment regimen of 300 mg anifrolumab (MEDI-546) every 4 weeks (Q4W) for eligible patients with moderate-to-severe active SLE while receiving standard therapy.

Also known as: MEDI-546, D3461

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Clinigen, Inc.: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 11, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-04