Clinical Trials

Date: 2018-08-31

Type of information: Results

phase: 3

Announcement: results

Company: AstraZeneca (UK)

Product: anifrolumab

Action mechanism:

• monoclonal antibody. Anifrolumab is a new monoclonal antibody against the type I interferon (IFN) receptor that inhibits the activity of all type I IFNs, which play a central role in lupus. Anifrolumab (formerly MEDI-546) is an investigational, fully human monoclonal antibody that binds to subunit 1 of the Type I IFN receptor, inhibiting the activity of all Type I IFNs. Anifrolumab is the only anti-type-I IFN receptor approach currently in development for SLE.
• Anifrolumab is also being tested in a Phase III SLE long-term extension trial, a Phase II trial using subcutaneous delivery in SLE and a Phase II trial for lupus nephritis.

Disease: moderate-to-severe systemic lupus erythematosus (SLE)

Therapeutic area: Autoimmune diseases

Country: Argentina, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Germany, Japan, Republic of Korea, Lithuania, Mexico, Russian Federation, Singapore, South Africa, Spain, USA

Trial details:

• The pivotal TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) programme includes two Phase III clinical trials, TULIP 1 and TULIP 2, that are evaluating the efficacy and safety of anifrolumab versus placebo in patients with moderately-to-severely active autoantibody-positive SLE who are receiving standard of care treatment. TULIP 1 randomised 460 eligible patients (1:2:2) to receive a fixed-dose intravenous infusion of 150mg anifrolumab, 300mg anifrolumab, or placebo every 4 weeks. TULIP 2 randomised 373 eligible patients (1:1) to receive a fixed-dose intravenous infusion of 300mg anifrolumab or placebo every 4 weeks. (NCT02446912 and NCT02446899)

Latest news:

• • On August 31, 2018, AstraZeneca and MedImmune, its global biologics research and development arm, announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE).
• The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months. The pivotal Phase III TULIP 1 trial was a randomised, double-blinded, 52-week placebo-controlled, multi-centre trial assessing the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.
• A full evaluation of the data will be conducted when TULIP 2 data are available later this year. TULIP 1 data will be presented at a future medical meeting.
• • On November 10, 2015, AstraZeneca announced that the anifrolumab Phase III programme was initiated in July.

Is general: Yes