Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis

The purpose of this multinational, randomized, placebo-controlled, and double-blind study is to evaluate the safety and efficacy of subcutaneous anifrolumab in adult patients with systemic sclerosis, who may be taking one or a combination of protocol-specified standard therapies. Following 52-weeks of double-blind, placebo-controlled treatment, a 52-week open-label treatment period is included to assess long-term safety in systemic sclerosis.

Eligibility criteria:

• Confirmed diagnosis of SSc according to 2013 ACR/EULAR classification criteria
• Disease duration ≤ 6 years from first non-Raynaud phenomenon manifestation
• mRSS > 10 at screening for those with disease duration < 18 months
• mRSS ≥ 15 at screening for those with disease duration ≥ 18 months.

AND active disease at screening with at least one of the following:

• CRP ≥ 6mg/L or ESR > 20mm/h or PLT ≥ 330 x 109/L
• Diagnosis of interstitial lung disease confirmed by HRCT (no minimum)
• Documentation of new skin involvement/progression by mRSS ≥ 3 units within last 6 months
• Documentation of tendon friction rubs within last 3 months