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Long‑term Safety and Tolerability of Anifrolumab in Adults with Systemic Lupus Erythematosus Who Completed Prior Study

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves people with several autoimmune conditions, including Systemic Sclerosis (a disease that causes hardening of the skin and internal organs), Cutaneous Lupus Erythematosus (a form of lupus that mainly affects the skin), Myopathies (muscle‑related disorders), and Systemic Lupus Erythematosus (a disease that can affect many parts of the body). The medication being used is anifrolumab, sold under the brand name Saphnelo. It can be given either by intravenous infusion (a drip placed into a vein) or by subcutaneous injection (a shot placed just under the skin).

The purpose of the study is to provide continued treatment to participants who have already shown benefit and to monitor the long‑term safety and tolerability of the medication. Participants who have completed an earlier trial may receive the drug at regular intervals for an extended period, with periodic clinic visits to check for any side effects and to assess overall health. Follow‑up continues for several weeks after the final dose to ensure any late‑appearing effects are recorded.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Confirmation

    After joining the study, the investigator checks that you completed the previous trial and that you continued to benefit from the treatment.

    You sign a consent form that explains the purpose of the rollover study.

  2. Step 2

    Baseline Assessments

    A series of medical tests, blood work, and questionnaires are performed to record your health status before the first dose.

    These assessments help the study team compare future results with your starting condition.

  3. Step 3

    First Treatment Administration

    You receive the first dose of Saphnelo, which contains the active substance anifrolumab.

    The first dose may be given as a 300 mg intravenous (IV) infusion (injected into a vein) or as a 120 mg subcutaneous injection (injected under the skin) using a pre‑filled syringe, according to the study protocol.

  4. Step 4

    Ongoing Treatment Visits

    You return for additional doses of Saphnelo at the intervals scheduled by the investigator.

    Each dose uses the same amount and method (either the 300 mg IV infusion or the 120 mg subcutaneous injection) as described for the first treatment.

    The total length of treatment continues until the study ends or the investigator decides to stop the medication.

  5. Step 5

    Safety Monitoring

    During each visit, the study team checks your vital signs, performs laboratory tests, and asks about any side effects.

    You are asked to report any serious adverse events (SAEs), which are health problems that require hospitalization or are life‑threatening, as well as any other adverse events (AEs), which are any unwanted symptoms you experience.

    All reported events are recorded and evaluated throughout the study.

  6. Step 6

    Post‑Treatment Follow‑Up

    After the last dose of Saphnelo, you continue to be monitored for an additional 12 weeks.

    During this period, the same safety assessments are performed to observe any delayed effects of the medication.

  7. Step 7

    Final Study Visit

    At the end of the follow‑up period, a final visit is scheduled to complete all remaining assessments.

    The study data are then closed, and you are thanked for your participation.

Who can join the trial?

6 criteria

  • You must have finished the whole earlier trial (the parent study) and have received at least one dose of the medicine called anifrolumab during that study.
  • The doctor must think that staying on anifrolumab after the earlier trial is more helpful than risky for you.
  • You need to use birth‑control methods (called contraception) that follow the rules of your country, and keep using them for up to 16 weeks after the last dose of the study drug.
  • You must be able to sign a document that explains the study and your rights (this is called informed consent) and agree to follow the study rules.
  • You must be able to follow the treatment schedule and study procedures for this trial.
  • Both men and women can join, and the study includes people of any age.

Who cannot join the trial?

10 criteria

  • If you are allergic (hypersensitivity) to any part of the study drug anifrolumab, you cannot join.
  • If the approved medicine for your condition is already available to you locally, you cannot join.
  • If you are a female who is breastfeeding, pregnant, or plans to become pregnant while the study is happening, you cannot join.
  • If you are currently taking part in another research study, or have taken part in one within the last 30 days, or within five half‑lives (the time it takes for half of a drug to leave your body) of another study drug, you cannot join.
  • If you have an ongoing, unresolved adverse event (a problem caused by a medicine) that required stopping treatment at the end of the earlier study, and the doctor thinks it would stop you from restarting the drug, you cannot join.
  • If you are currently using, or have used, medicines that the study says are not allowed (prohibited medications), you cannot join.
  • If you plan to receive live or live‑attenuated vaccines (vaccines that contain a weakened form of the germ), you cannot join.
  • If you plan to use any other treatments, including B‑cell therapies (drugs that target a type of immune cell), that the doctor believes could affect your participation, you cannot join.
  • If you have a serious medical condition such as cancer or a viral infection like hepatitis, or a serious psychiatric (mental health) condition, that the doctor believes would make it unsafe or difficult to stay in the study, you cannot join.
  • If you stopped the earlier (parent) study before completing all required visits, you cannot join.
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Investigated drugs

  • Saphnelo (intravenous infusion)

    is a medication given through a vein using a drip. It contains a protein that helps calm an over‑active immune system. In this trial participants who have already shown improvement continue receiving the infusion to see how safe and well‑tolerated it remains over a longer period.

  • Saphnelo (subcutaneous injection)

    is the same medication but provided as a ready‑to‑use liquid that is injected just under the skin. This form also works to reduce the immune system’s excessive activity. Participants who benefit from the treatment can keep receiving the injection while researchers watch for any long‑term side effects and overall safety.

What is already known about the treatment

Saphnelo (anifrolumab) - Saphnelo is given either as a concentrate that is mixed for intravenous infusion or as a ready‑to‑use solution injected under the skin with a prefilled syringe. It is an approved biologic medicine and is described in current medical literature as a treatment for systemic lupus erythematosus and related autoimmune skin and muscle conditions. The drug works by binding to the type‑I interferon receptor on immune cells, blocking the signal that drives inflammation. It belongs to the class of monoclonal antibodies that target the interferon‑alpha receptor, known as an anti‑interferon‑alpha receptor antibody.

Investigated diseases

  • Systemic sclerosis

    a chronic condition that causes thickening and hardening of the skin and may affect internal organs. It begins with swelling and tightness of the skin, often on the fingers and face. Over time the skin can become rigid and may limit movement. Blood vessels can become narrowed, leading to reduced blood flow. Some internal organs such as the lungs or heart can develop fibrosis as the disease progresses.

  • Cutaneous lupus erythematosus

    an autoimmune skin disorder that produces red, scaly patches or lesions. The rash often appears on sun‑exposed areas such as the face, neck, and arms. Lesions may flare after sunlight exposure and can cause itching or burning. With ongoing disease activity, the skin changes can become more persistent and may lead to pigment changes or scarring.

  • Myopathies

    a group of disorders that cause weakness and inflammation of the skeletal muscles. Symptoms usually start with difficulty climbing stairs, lifting objects, or rising from a seated position. Muscle weakness can spread to other parts of the body and may lead to fatigue. In some cases, muscle tissue can become inflamed, resulting in tenderness or swelling. Persistent disease can limit daily activities and reduce overall mobility.

  • Systemic lupus erythematosus

    a systemic autoimmune disease that can involve the skin, joints, kidneys, brain, and other organs. It often begins with joint pain, fever, and a characteristic butterfly rash on the face. The immune system attacks healthy tissues, causing inflammation that can affect many body parts. Symptoms may come and go, with periods of increased activity followed by quieter phases. Ongoing inflammation can lead to cumulative organ involvement over time.

Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526419-13-00Protocol codeD346BC00004Estimated enrolment804 patientsSponsorAstraZeneca AB

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