A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
LaunchPAD-RA
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)
3 other identifiers
interventional
320
17 countries
144
Brief Summary
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Dec 2025
Longer than P75 for phase_2 rheumatoid-arthritis
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 18, 2028
May 5, 2026
April 1, 2026
1.9 years
December 1, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12
Change from baseline in DAS28-CRP at Week 12.
Week 12
Secondary Outcomes (6)
Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12
Week 12
Percentage of Participants Achieving ACR50 at Week 12
Week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
Week 12
Summary statistics to evaluate the PK of AZD1163
Week 0 to Week 24 and Follow-Up
- +1 more secondary outcomes
Study Arms (4)
AZD1163 Dose 1
EXPERIMENTALParticipants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
AZD1163 Dose 2
EXPERIMENTALParticipants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
AZD1163 Dose 3
EXPERIMENTALParticipants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Placebo
PLACEBO COMPARATORParticipants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Interventions
Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (144)
Research Site
Glendale, Arizona, 85306, United States
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Prescott Valley, Arizona, 86314, United States
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Tucson, Arizona, 85748, United States
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La Jolla, California, 92037, United States
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San Dimas, California, 91773, United States
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San Leandro, California, 94578, United States
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Aurora, Colorado, 80045, United States
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Boynton Beach, Florida, 33435, United States
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Jacksonville, Florida, 32216, United States
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South Miami, Florida, 33143, United States
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Tampa, Florida, 33607, United States
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Winter Haven, Florida, 33880, United States
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Marietta, Georgia, 30060, United States
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Skokie, Illinois, 60076, United States
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Willowbrook, Illinois, 60527, United States
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Lake Charles, Louisiana, 70605, United States
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Baltimore, Maryland, 21224, United States
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New Bedford, Massachusetts, 02740, United States
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Kansas City, Missouri, 64151, United States
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St Louis, Missouri, 63131, United States
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Henderson, Nevada, 89052, United States
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Myrtle Beach, South Carolina, 29572, United States
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Austin, Texas, 78745, United States
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Baytown, Texas, 77521, United States
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Houston, Texas, 77027, United States
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Houston, Texas, 77089, United States
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Mesquite, Texas, 75150, United States
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Tomball, Texas, 77375, United States
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Caba, C1128AAF, Argentina
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Ciudad de Buenos Aires, C1015ABO, Argentina
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Ciudad de Buenos Aires, C1428DUQ, Argentina
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Córdoba, X5000EDC, Argentina
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San Isidro, 1643, Argentina
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San Miguel de Tucumán, T4000AXL, Argentina
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Juiz de Fora, 36010 570, Brazil
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Pelotas, 96040-010, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 9061-000, Brazil
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Salvador, 41820-020, Brazil
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São Paulo, 04266-010, Brazil
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São Paulo, 05403-9000, Brazil
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Haskovo, 6304, Bulgaria
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Pleven, 5800, Bulgaria
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Sofia, 1113, Bulgaria
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Sofia, 1336, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1612, Bulgaria
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Windsor, Ontario, N8X 5A7, Canada
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Trois-Rivières, Quebec, G9A 3Y2, Canada
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Providencia, 7510186, Chile
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Santiago, 7500571, Chile
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Santiago, 7500587, Chile
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Temuco, 4810345, Chile
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Valdivia, 5110683, Chile
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Victoria, 4720097, Chile
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Viña del Mar, 2531172, Chile
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Beijing, 100144, China
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Beijing, 100730, China
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Changchun, 130021, China
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Changsha, 410008, China
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Guangzhou, 510515, China
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Jiujiang, 332000, China
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Kunming, 650032, China
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Linyi, CN-276003, China
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Nanchong, 637000, China
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Panjin, 124000, China
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Pingxiang, 337055, China
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Shantou, 515041, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Zhengzhou, 450000, China
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Bad Doberan, 18209, Germany
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Berlin, 12161, Germany
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Hamburg, 20095, Germany
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Sendenhorst, 48324, Germany
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Budapest, 1023, Hungary
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Budapest, 1027, Hungary
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Budapest, 1036, Hungary
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Debrecen, 4032, Hungary
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Gyula, 5700, Hungary
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Szeged, 6725, Hungary
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Székesfehérvár, 8000, Hungary
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Veszprém, 8200, Hungary
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Aomori, 030-8553, Japan
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Bunkyō City, 113-8655, Japan
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Fukuoka, 815-8555, Japan
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Hamamatsu, 430-0906, Japan
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Hitachi-Naka, 312-0057, Japan
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Iizuka-shi, 820-8505, Japan
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Kawachinagano-shi, 586-8521, Japan
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Matsuyama, 790-8524, Japan
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Meguro-ku, 152-8902, Japan
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Miyazaki, 880-0834, Japan
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Nagoya, 457-8511, Japan
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Okayama, 700-8557, Japan
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Sagamihara-shi, 252-0315, Japan
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Sapporo, 060-0001, Japan
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Sasebo-shi, 857-1195, Japan
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Sayama-shi, 350-1305, Japan
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Yokohama, 236-0037, Japan
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Chihuahua City, 31000, Mexico
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Estado de México, 50090, Mexico
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Guadalajara, 44160, Mexico
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Guadalajara, 44650, Mexico
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Guadalajara, 44690, Mexico
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Gustavo A. Madero, 07300, Mexico
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Mexicali, 021100, Mexico
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Mexico City, 06700, Mexico
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Mérida, 97070, Mexico
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Monterrey, 64460, Mexico
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San Luis Potosí City, 78213, Mexico
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Krakow, 30-002, Poland
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Krakow, 30-727, Poland
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Torun, 87-100, Poland
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Warsaw, 00-874, Poland
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Wroclaw, 50-244, Poland
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Caguas, 00725, Puerto Rico
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Brackenfell, 7560, South Africa
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Cape Town, 7500, South Africa
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Durban, 4319, South Africa
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Pinelands, 7405, South Africa
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Pretoria, 0002, South Africa
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Pretoria, South Africa
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Somerset West, 7130, South Africa
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08041, Spain
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Málaga, 29009, Spain
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Sabadell, 08208, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46026, Spain
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Ivano-Frankivsk, 76018, Ukraine
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Kyiv, 02002, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04210, Ukraine
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Uzhhorod, 88000, Ukraine
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Vinnytsia, 21018, Ukraine
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Vinnytsia, 21029, Ukraine
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Glasgow, G31 2ER, United Kingdom
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Leeds, LS7 4SA, United Kingdom
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Luton, LU4 0DZ, United Kingdom
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Staffordshire, WS11 5XY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2025
First Posted
December 11, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
November 12, 2027
Study Completion (Estimated)
August 18, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.