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

NCT07276581 · AstraZeneca
In plain English

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Official title
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)
About this study
AZD1163 is a novel bispecific antibody that inhibits the activity of extracellular peptidyl arginine deiminase 2 (PAD2) and peptidyl arginine deiminase 4 (PAD4) enzymes, which are responsible for protein citrullination. In RA, citrullinated proteins lead to the production of pathogenic anti-citrullinated peptide antibodies (ACPA). This is a Phase II, randomised, double-blind, multicentre, 4 arm placebo-controlled study designed to evaluate the efficacy and safety of AZD1163 in ACPA + adults with moderate-to-severely active RA on standard of care (SoC) (conventional synthetic disease-modifying antirheumatic drugs \[csDMARDs\] or tumour necrosis factor inhibitor \[TNFi\] +/- csDMARD). The study will have a screening period followed by a randomisation period wherein approximately 320 participants will be randomised in a 1:1:1:1 ratio to receive study intervention. Participants will receive subcutaneous (SC) injection of one of three different doses of AZD1163 or placebo, along with SoC until Week 24 followed by a safety follow-up (FU) period of 28 days.
Eligibility criteria
* Inclusion * Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening. * Moderately-to-severely active RA as defined by: a. \>= 6 swollen joints on 66SJC and \>= 6 tender joints on 68TJC; b. CRP \> upper limit of normal. * Have a positive ACPA at screening. * A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND/OR b. At least one and at most 2 TNFi. * A history of at least 12 weeks treatment and \>= 4 weeks stable on a csDMARD and/or SC TNFi prior to the day of randomisation. * Exclusion * History or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren's disease are eligible. * Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.
Study design
Enrollment target: 320 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-15
Estimated completion: 2028-08-18
Last updated: 2026-03-24
Interventions
Drug: AZD1163Other: Placebo
Primary outcomes
  • Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 (Week 12)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (139)
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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
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis · TrialPath