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)
Status: Recruiting
Location: See all (144) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
Arizona
Research Site
NOT_YET_RECRUITING
Glendale
Research Site
WITHDRAWN
Prescott Valley
Research Site
NOT_YET_RECRUITING
Tucson
California
Research Site
NOT_YET_RECRUITING
La Jolla
Research Site
WITHDRAWN
San Dimas
Research Site
NOT_YET_RECRUITING
San Leandro
Colorado
Research Site
NOT_YET_RECRUITING
Aurora
Florida
Research Site
WITHDRAWN
Boynton Beach
Research Site
WITHDRAWN
Jacksonville
Research Site
RECRUITING
South Miami
Research Site
WITHDRAWN
Tampa
Research Site
NOT_YET_RECRUITING
Winter Haven
Georgia
Research Site
NOT_YET_RECRUITING
Marietta
Illinois
Research Site
NOT_YET_RECRUITING
Skokie
Research Site
RECRUITING
Willowbrook
Louisiana
Research Site
NOT_YET_RECRUITING
Lake Charles
Massachusetts
Research Site
RECRUITING
New Bedford
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
Missouri
Research Site
NOT_YET_RECRUITING
Kansas City
Research Site
NOT_YET_RECRUITING
St Louis
Nevada
Research Site
RECRUITING
Henderson
South Carolina
Research Site
NOT_YET_RECRUITING
Myrtle Beach
Texas
Research Site
RECRUITING
Austin
Research Site
RECRUITING
Baytown
Research Site
NOT_YET_RECRUITING
Houston
Research Site
RECRUITING
Houston
Research Site
NOT_YET_RECRUITING
Mesquite
Research Site
RECRUITING
Tomball
Other Locations
Argentina
Research Site
NOT_YET_RECRUITING
Caba
Research Site
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Research Site
NOT_YET_RECRUITING
Ciudad De Buenos Aires
Research Site
NOT_YET_RECRUITING
Córdoba
Research Site
NOT_YET_RECRUITING
San Isidro
Research Site
NOT_YET_RECRUITING
San Miguel De Tucumán
Brazil
Research Site
NOT_YET_RECRUITING
Juiz De Fora
Research Site
NOT_YET_RECRUITING
Pelotas
Research Site
NOT_YET_RECRUITING
Porto Alegre
Research Site
NOT_YET_RECRUITING
Porto Alegre
Research Site
NOT_YET_RECRUITING
Salvador
Research Site
NOT_YET_RECRUITING
São Paulo
Research Site
WITHDRAWN
São Paulo
Bulgaria
Research Site
NOT_YET_RECRUITING
Haskovo
Research Site
NOT_YET_RECRUITING
Pleven
Research Site
NOT_YET_RECRUITING
Sofia
Research Site
NOT_YET_RECRUITING
Sofia
Research Site
NOT_YET_RECRUITING
Sofia
Research Site
NOT_YET_RECRUITING
Sofia
Canada
Research Site
RECRUITING
Trois-rivières
Research Site
RECRUITING
Windsor
Chile
Research Site
NOT_YET_RECRUITING
Providencia
Research Site
NOT_YET_RECRUITING
Santiago
Research Site
NOT_YET_RECRUITING
Santiago
Research Site
NOT_YET_RECRUITING
Temuco
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NOT_YET_RECRUITING
Valdivia
Research Site
NOT_YET_RECRUITING
Victoria
Research Site
NOT_YET_RECRUITING
Viña Del Mar
China
Research Site
NOT_YET_RECRUITING
Beijing
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NOT_YET_RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Changchun
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Jiujiang
Research Site
NOT_YET_RECRUITING
Kunming
Research Site
NOT_YET_RECRUITING
Linyi
Research Site
NOT_YET_RECRUITING
Nanchong
Research Site
NOT_YET_RECRUITING
Panjin
Research Site
NOT_YET_RECRUITING
Pingxiang
Research Site
NOT_YET_RECRUITING
Shantou
Research Site
NOT_YET_RECRUITING
Xuzhou
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NOT_YET_RECRUITING
Yangzhou
Research Site
NOT_YET_RECRUITING
Zhengzhou
Germany
Research Site
NOT_YET_RECRUITING
Bad Doberan
Research Site
NOT_YET_RECRUITING
Berlin
Research Site
NOT_YET_RECRUITING
Hamburg
Research Site
NOT_YET_RECRUITING
Sendenhorst
Hungary
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
NOT_YET_RECRUITING
Budapest
Research Site
NOT_YET_RECRUITING
Debrecen
Research Site
NOT_YET_RECRUITING
Gyula
Research Site
NOT_YET_RECRUITING
Szeged
Research Site
NOT_YET_RECRUITING
Székesfehérvár
Research Site
NOT_YET_RECRUITING
Veszprém
Japan
Research Site
NOT_YET_RECRUITING
Aomori
Research Site
NOT_YET_RECRUITING
Bunkyō City
Research Site
NOT_YET_RECRUITING
Fukuoka
Research Site
NOT_YET_RECRUITING
Hamamatsu
Research Site
NOT_YET_RECRUITING
Hitachi-naka
Research Site
NOT_YET_RECRUITING
Iizuka-shi
Research Site
NOT_YET_RECRUITING
Kawachinagano-shi
Research Site
NOT_YET_RECRUITING
Matsuyama
Research Site
NOT_YET_RECRUITING
Meguro-ku
Research Site
NOT_YET_RECRUITING
Miyazaki
Research Site
NOT_YET_RECRUITING
Nagoya
Research Site
WITHDRAWN
Okayama
Research Site
NOT_YET_RECRUITING
Sagamihara-shi
Research Site
WITHDRAWN
Sapporo
Research Site
RECRUITING
Sasebo-shi
Research Site
NOT_YET_RECRUITING
Sayama-shi
Research Site
NOT_YET_RECRUITING
Yokohama
Mexico
Research Site
NOT_YET_RECRUITING
Chihuahua City
Research Site
NOT_YET_RECRUITING
Estado De México
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Gustavo A. Madero
Research Site
NOT_YET_RECRUITING
Mérida
Research Site
NOT_YET_RECRUITING
Mexicali
Research Site
NOT_YET_RECRUITING
Mexico City
Research Site
NOT_YET_RECRUITING
Monterrey
Research Site
WITHDRAWN
San Luis Potosí City
Poland
Research Site
NOT_YET_RECRUITING
Krakow
Research Site
NOT_YET_RECRUITING
Krakow
Research Site
NOT_YET_RECRUITING
Torun
Research Site
NOT_YET_RECRUITING
Warsaw
Research Site
NOT_YET_RECRUITING
Wroclaw
Puerto Rico
Research Site
NOT_YET_RECRUITING
Caguas
South Africa
Research Site
NOT_YET_RECRUITING
Brackenfell
Research Site
NOT_YET_RECRUITING
Cape Town
Research Site
NOT_YET_RECRUITING
Durban
Research Site
NOT_YET_RECRUITING
Pinelands
Research Site
NOT_YET_RECRUITING
Pretoria
Research Site
NOT_YET_RECRUITING
Pretoria
Research Site
NOT_YET_RECRUITING
Somerset West
Spain
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Málaga
Research Site
NOT_YET_RECRUITING
Sabadell
Research Site
NOT_YET_RECRUITING
Santiago De Compostela
Research Site
NOT_YET_RECRUITING
Valencia
Ukraine
Research Site
RECRUITING
Ivano-frankivsk
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Uzhhorod
Research Site
RECRUITING
Vinnytsia
Research Site
RECRUITING
Vinnytsia
United Kingdom
Research Site
RECRUITING
Glasgow
Research Site
RECRUITING
Leeds
Research Site
NOT_YET_RECRUITING
Luton
Research Site
NOT_YET_RECRUITING
Staffordshire
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2028-08-18
Participants
Target number of participants: 320
Treatments
Experimental: AZD1163 Dose 1
Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Experimental: AZD1163 Dose 2
Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Experimental: AZD1163 Dose 3
Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Placebo_comparator: Placebo
Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca