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 (139) 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WITHDRAWN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WITHDRAWN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
NOT_YET_RECRUITING
Avon Park
Research Site
WITHDRAWN
Boynton Beach
Research Site
WITHDRAWN
Jacksonville
Research Site
RECRUITING
South Miami
Research Site
WITHDRAWN
Tampa
Illinois
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
St Louis
Nevada
Research Site
RECRUITING
Henderson
South Carolina
Research Site
NOT_YET_RECRUITING
Myrtle Beach
Texas
Research Site
NOT_YET_RECRUITING
Austin
Research Site
RECRUITING
Baytown
Research Site
NOT_YET_RECRUITING
Houston
Research Site
NOT_YET_RECRUITING
Houston
Research Site
NOT_YET_RECRUITING
Mesquite
Research Site
NOT_YET_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
NOT_YET_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
Research Site
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
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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
NOT_YET_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
Mexico City
Research Site
NOT_YET_RECRUITING
Monterrey
Research Site
SUSPENDED
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
Stellenbosch
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
NOT_YET_RECRUITING
Kyiv
Research Site
NOT_YET_RECRUITING
Uzhhorod
Research Site
RECRUITING
Vinnytsia
Research Site
RECRUITING
Vinnytsia
United Kingdom
Research Site
NOT_YET_RECRUITING
Glasgow
Research Site
NOT_YET_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