RecruitingPhase 2NCT07276581

A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis

A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)

Sponsor

AstraZeneca

Enrollment

320 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called AZD1163 for adults with rheumatoid arthritis (RA) — a condition where the immune system attacks the joints — that has not been controlled well enough by standard treatments. **You may be eligible if...** - You have been diagnosed with RA for at least 12 weeks - Your RA is moderately to severely active (swollen and tender joints, elevated inflammation markers) - You have a positive ACPA blood test (a marker for RA) - You have tried at least one standard RA drug (like methotrexate) and/or at most two TNF inhibitors, but they didn't work well enough - You have been on a stable dose of your current RA medication for at least 4 weeks **You may NOT be eligible if...** - You have a different autoimmune condition that could be confused with RA (secondary Sjogren's is an exception) - You have previously used biologic DMARDs other than TNF inhibitors, or targeted synthetic DMARDs (like JAK inhibitors) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD1163

Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

OTHERPlacebo

Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

Locations(139)

Research Site

Glendale, Arizona, United States

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Prescott Valley, Arizona, United States

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Tucson, Arizona, United States

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La Jolla, California, United States

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San Dimas, California, United States

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San Leandro, California, United States

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Aurora, Colorado, United States

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Avon Park, Florida, United States

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Boynton Beach, Florida, United States

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Jacksonville, Florida, United States

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South Miami, Florida, United States

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Tampa, Florida, United States

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Willowbrook, Illinois, United States

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Lake Charles, Louisiana, United States

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Baltimore, Maryland, United States

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New Bedford, Massachusetts, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Myrtle Beach, South Carolina, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Mesquite, Texas, United States

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Tomball, Texas, United States

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Caba, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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San Isidro, Argentina

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San Miguel de Tucumán, Argentina

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Juiz de Fora, Brazil

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Pelotas, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Haskovo, Bulgaria

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Pleven, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Windsor, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Providencia, Chile

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Santiago, Chile

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Santiago, Chile

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Temuco, Chile

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Valdivia, Chile

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Victoria, Chile

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Viña del Mar, Chile

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Guangzhou, China

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Jiujiang, China

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Kunming, China

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Linyi, China

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Nanchong, China

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Panjin, China

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Pingxiang, China

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Shantou, China

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Xuzhou, China

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Yangzhou, China

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Zhengzhou, China

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Berlin, Germany

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Hamburg, Germany

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Sendenhorst, Germany

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Gyula, Hungary

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Szeged, Hungary

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Székesfehérvár, Hungary

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Veszprém, Hungary

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Aomori, Japan

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Bunkyō City, Japan

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Fukuoka, Japan

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Hamamatsu, Japan

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Hitachi-Naka, Japan

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Iizuka-shi, Japan

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Kawachinagano-shi, Japan

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Matsuyama, Japan

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Meguro-ku, Japan

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Miyazaki, Japan

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Nagoya, Japan

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Okayama, Japan

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Sagamihara-shi, Japan

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Sapporo, Japan

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Sasebo-shi, Japan

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Sayama-shi, Japan

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Yokohama, Japan

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Chihuahua City, Mexico

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Estado de México, Mexico

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Guadalajara, Mexico

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Guadalajara, Mexico

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Guadalajara, Mexico

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Gustavo A. Madero, Mexico

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Mexico City, Mexico

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Mérida, Mexico

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Monterrey, Mexico

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San Luis Potosí City, Mexico

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Krakow, Poland

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Krakow, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Caguas, Puerto Rico

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Brackenfell, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Pinelands, South Africa

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Pretoria, South Africa

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Pretoria, South Africa

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Stellenbosch, South Africa

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Málaga, Spain

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Sabadell, Spain

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Santiago de Compostela, Spain

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Valencia, Spain

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Ivano-Frankivsk, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Uzhhorod, Ukraine

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Vinnytsia, Ukraine

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Vinnytsia, Ukraine

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Glasgow, United Kingdom

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Leeds, United Kingdom

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Luton, United Kingdom

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Staffordshire, United Kingdom

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NCT07276581

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