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CAR-T study in SLE, IIM and SSc

24-0289

• Adult women or men (age 18 and above) with confirmed, active SLE, IIM, SSc
• Fulfilling the 2013 EULAR/ACR classification criteria for probable or definite SSc.
• Antinuclear Antibody (ANA) positive at screening or prior to screening
• with diffuse cutaneous SSc meeting the following criteria: Disease duration ≤ 5 years (from onset of first non-Raynaud manifestation) AND mRSS ≥ 15 at screening AND mRSS increase ≥ 3 units or involvement of 1 new body area, or mRSS increase ≥ 2 units in 1 body area over 6 months AND At least one: C-reactive protein ≥ 10·0 mg/L, erythrocyte sedimentation rate ≥ 28 mm/h, OR Health Assessment Questionnaire – Disability Index (HAQ-DI) > 1.0
• Or participants diagnosed with diffuse or limited cutaneous SSc AND progressive ILD on HRCT and ≤ 5 years duration (from onset of first non-Raynaud manifestation) 
• AND inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or IVIG.
• Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren’s syndrome are not excluded.

Chong Pedrick

303-724-7518

Chong.Pedrick@cuanschutz.edu

Najeeb Arishi

303-724-7512

Najeeb.Arishi@cuanschutz.edu

Mario Farag

303-724-6438

DAISY -AstraZeneca AB

IRB# 24-1892

PI-Melissa Griffith, M.D.

Phase 3

The purpose of this multinational, randomized, placebo-controlled, and double-blind study is to evaluate the safety and efficacy of subcutaneous (SC) anifrolumab in adult patients with systemic sclerosis (SSc), 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 SSc.

Participant must be 18 to 70 years of age inclusive, at the time of signing the ICF.

Participants must have: 

-Limited or diffuse cutaneous subsets SSc. 

- SSc disease duration ≤ 6 years from first non-Raynaud’s phenomenon manifestation at
the time of signing the ICF.

Please contact the Study Coordinator at

Primary Contact:

najeeb.arishi@cuanschutz.edu or 303-724-7513

Secondary Contact:

mario.farag@cuanschutz.edu or 303-724-6438 

chong.pedrick@cuanschutz.edu or 303-724-7518

Study link: