Subcutaneous Anifrolumab in Adult Patients With Lupus

RECRUITING

I'm interested ...!!

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

Conditions:

🦠 Systemic Lupus Erythematosus

🗓️ Study Start (Actual) 8 June 2021

🗓️ Primary Completion (Estimated) 29 August 2025

✅ Study Completion (Estimated) 11 December 2026

👥 Enrollment (Estimated) 360

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Anniston, Alabama, United States

📍 Birmingham, Alabama, United States

📍 Paradise Valley, Arizona, United States

📍 Phoenix, Arizona, United States

📍 El Cajon, California, United States

📍 Fullerton, California, United States

📍 Hemet, California, United States

📍 La Mesa, California, United States

📍 Los Angeles, California, United States

📍 Menifee, California, United States

📍 Upland, California, United States

📍 Aurora, Colorado, United States

📍 Denver, Colorado, United States

📍 Boynton Beach, Florida, United States

📍 Brandon, Florida, United States

📍 Clearwater, Florida, United States

📍 Hialeah, Florida, United States

📍 Miami, Florida, United States

📍 Tampa, Florida, United States

📍 Decatur, Georgia, United States

📍 Lawrenceville, Georgia, United States

📍 Idaho Falls, Idaho, United States

📍 Boston, Massachusetts, United States

📍 Flint, Michigan, United States

📍 Lansing, Michigan, United States

📍 Saint Louis, Missouri, United States

📍 Newark, New Jersey, United States

📍 Voorhees, New Jersey, United States

📍 Las Cruces, New Mexico, United States

📍 Bronx, New York, United States

📍 Brooklyn, New York, United States

📍 Manhasset, New York, United States

📍 New Hyde Park, New York, United States

📍 New York, New York, United States

📍 Potsdam, New York, United States

📍 Charlotte, North Carolina, United States

📍 Oklahoma City, Oklahoma, United States

📍 Pittsburgh, Pennsylvania, United States

📍 Reading, Pennsylvania, United States

📍 Memphis, Tennessee, United States

📍 Austin, Texas, United States

📍 El Paso, Texas, United States

📍 Grapevine, Texas, United States

📍 Ciudad de Buenos Aires, Argentina

📍 Córdoba, Argentina

📍 La Plata, Argentina

📍 Mendoza, Argentina

📍 Pergamino, Argentina

📍 Quilmes, Argentina

📍 Rosario, Argentina

📍 Salta, Argentina

📍 San Isidro, Argentina

📍 San Juan, Argentina

📍 San Miguel de Tucuman, Argentina

📍 Kardzhali, Bulgaria

📍 Pleven, Bulgaria

📍 Plovdiv, Bulgaria

📍 Sevlievo, Bulgaria

📍 Sofia, Bulgaria

📍 Osorno, Chile

📍 Santiago, Chile

📍 Valdivia, Chile

📍 Barranquilla, Colombia

📍 Bogota, Colombia

📍 Bucaramanga, Colombia

📍 Chia, Colombia

📍 Medellin, Colombia

📍 Monteria, Colombia

📍 Berlin, Germany

📍 Dresden, Germany

📍 Kirchheim, Germany

📍 Köln, Germany

📍 Leipzig, Germany

📍 Tuebingen, Germany

📍 Budapest, Hungary

📍 Gyula, Hungary

📍 Szekesfehervar, Hungary

📍 Veszprem, Hungary

📍 Chiba-shi, Japan

📍 Chuo-ku, Japan

📍 Hamamatsu-shi, Japan

📍 Hiroshima-shi, Japan

📍 Itabashi-ku, Japan

📍 Kawasaki-shi, Japan

📍 Kita-gun, Japan

📍 Kitakyushu-shi, Japan

📍 Meguro-ku, Japan

📍 Nagasaki-shi, Japan

📍 Nagoya-shi, Japan

📍 Nagoya, Japan

📍 Okayama-shi, Japan

📍 Sagamihara-shi, Japan

📍 Sapporo-shi, Japan

📍 Sasebo-shi, Japan

📍 Sendai-shi, Japan

📍 Shinjuku-ku, Japan

📍 Suita-shi, Japan

📍 Takatsuki-shi, Japan

📍 Tsu-shi, Japan

📍 Tsukuba-shi, Japan

📍 Chihuahua, Mexico

📍 Culiacan, Mexico

📍 Durango, Mexico

📍 Guadalajara, Mexico

📍 Merida, Mexico

📍 Mexicali, Mexico

📍 Mexico, Mexico

📍 Lima, Peru

📍 Davao City, Philippines

📍 Iloilo, Philippines

📍 Lipa City, Philippines

📍 Makati City, Philippines

📍 Quezon City, Philippines

📍 Katowice, Poland

📍 Koscian, Poland

📍 Krakow, Poland

📍 Kraków, Poland

📍 Lublin, Poland

📍 Nowa Sól, Poland

📍 Ustron, Poland

📍 Warszawa, Poland

📍 Wroclaw, Poland

📍 Łódź, Poland

📍 Moscow, Russian Federation

📍 Ryazan, Russian Federation

📍 Saint-Petersburg, Russian Federation

📍 Saratov, Russian Federation

📍 Smolensk, Russian Federation

📍 Barcelona, Spain

📍 Madrid, Spain

📍 Santiago de Compostela, Spain

📍 Sevilla, Spain

📍 Valencia, Spain

📍 Muang, Thailand

📍 Rachathewi, Thailand

📍 Cherkasy, Ukraine

📍 Kryvyi Rih, Ukraine

📍 Kyiv, Ukraine

📍 Lviv, Ukraine

📍 Odesa, Ukraine

📍 Vinnytsia, Ukraine

📍 Zaporizhzhia, Ukraine

📍 Coventry, United Kingdom

📍 Doncaster, United Kingdom

📍 Edinburgh, United Kingdom

📍 Harlow, United Kingdom

📍 Leeds, United Kingdom

📍 Leytonstone, United Kingdom

📍 London, United Kingdom

📍 Wigan, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
3. BILAG2004 with at least 1 of the following:
1. BILAG2004 level A disease in ≥ 1 organ system
2. BILAG2004 level B disease in ≥ 2 organ systems
4. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

Exclusion Criteria:

7. Active severe or unstable neuropsychiatric SLE
8. Active severe SLE-driven renal disease
9. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
15. History of cancer, apart from:
1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 4 May 2021
First Submitted that Met QC Criteria 4 May 2021
First Posted 7 May 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 17 July 2024
Last Update Posted 18 July 2024
Last Verified July 2024