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)

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

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: AZD1163; Other: Placebo

Detailed Description

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 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Caba, Argentina, C1128AAF
    • Not yet recruiting
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1015ABO
    • Not yet recruiting
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  • Ciudad de Buenos Aires, Argentina, C1428DUQ
    • Not yet recruiting
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  • Córdoba, Argentina, X5000EDC
    • Not yet recruiting
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  • San Isidro, Argentina, 1643
    • Not yet recruiting
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  • San Miguel de Tucumán, Argentina, T4000AXL
    • Not yet recruiting
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• Brazil
  • Juiz de Fora, Brazil, 36010 570
    • Not yet recruiting
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  • Pelotas, Brazil, 96040-010
    • Not yet recruiting
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  • Porto Alegre, Brazil, 90035-903
    • Not yet recruiting
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  • Porto Alegre, Brazil, 9061-000
    • Not yet recruiting
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  • Salvador, Brazil, 41820-020
    • Not yet recruiting
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  • São Paulo, Brazil, 05403-9000
    • Not yet recruiting
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  • São Paulo, Brazil, 04266-010
    • Withdrawn
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• Bulgaria
  • Haskovo, Bulgaria, 6304
    • Not yet recruiting
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  • Pleven, Bulgaria, 5800
    • Not yet recruiting
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  • Sofia, Bulgaria, 1113
    • Not yet recruiting
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  • Sofia, Bulgaria, 1606
    • Not yet recruiting
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  • Sofia, Bulgaria, 1612
    • Not yet recruiting
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  • Sofia, Bulgaria, 1336
    • Not yet recruiting
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• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8X 5A7
      • Recruiting
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  • Quebec
    • Trois-Rivières, Quebec, Canada, G9A 3Y2
      • Recruiting
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• Chile
  • Providencia, Chile, 7510186
    • Not yet recruiting
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  • Santiago, Chile, 7500571
    • Not yet recruiting
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  • Santiago, Chile, 7500587
    • Not yet recruiting
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  • Temuco, Chile, 4810345
    • Not yet recruiting
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  • Valdivia, Chile, 5110683
    • Not yet recruiting
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  • Victoria, Chile, 4720097
    • Not yet recruiting
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  • Viña del Mar, Chile, 2531172
    • Not yet recruiting
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• China
  • Beijing, China, 100730
    • Not yet recruiting
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  • Beijing, China, 100144
    • Not yet recruiting
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  • Changchun, China, 130021
    • Not yet recruiting
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  • Changsha, China, 410008
    • Not yet recruiting
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  • Guangzhou, China, 510515
    • Not yet recruiting
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  • Jiujiang, China, 332000
    • Not yet recruiting
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  • Kunming, China, 650032
    • Not yet recruiting
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  • Linyi, China, CN-276003
    • Not yet recruiting
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  • Nanchong, China, 637000
    • Not yet recruiting
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  • Panjin, China, 124000
    • Not yet recruiting
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  • Pingxiang, China, 337055
    • Not yet recruiting
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  • Shantou, China, 515041
    • Not yet recruiting
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  • Xuzhou, China, 221009
    • Not yet recruiting
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  • Yangzhou, China, 225001
    • Not yet recruiting
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  • Zhengzhou, China, 450000
    • Not yet recruiting
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• Germany
  • Bad Doberan, Germany, 18209
    • Not yet recruiting
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  • Berlin, Germany, 12161
    • Not yet recruiting
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  • Hamburg, Germany, 20095
    • Not yet recruiting
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  • Sendenhorst, Germany, 48324
    • Not yet recruiting
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• Hungary
  • Budapest, Hungary, 1027
    • Not yet recruiting
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  • Budapest, Hungary, 1036
    • Not yet recruiting
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  • Budapest, Hungary, 1023
    • Not yet recruiting
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  • Debrecen, Hungary, 4032
    • Not yet recruiting
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  • Gyula, Hungary, 5700
    • Not yet recruiting
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  • Szeged, Hungary, 6725
    • Not yet recruiting
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  • Székesfehérvár, Hungary, 8000
    • Not yet recruiting
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  • Veszprém, Hungary, 8200
    • Not yet recruiting
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• Japan
  • Aomori, Japan, 030-8553
    • Not yet recruiting
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  • Bunkyō City, Japan, 113-8655
    • Not yet recruiting
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  • Fukuoka, Japan, 815-8555
    • Not yet recruiting
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  • Hamamatsu, Japan, 430-0906
    • Not yet recruiting
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  • Hitachi-Naka, Japan, 312-0057
    • Not yet recruiting
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  • Iizuka-shi, Japan, 820-8505
    • Not yet recruiting
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  • Kawachinagano-shi, Japan, 586-8521
    • Not yet recruiting
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  • Matsuyama, Japan, 790-8524
    • Not yet recruiting
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  • Meguro-ku, Japan, 152-8902
    • Not yet recruiting
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  • Miyazaki, Japan, 880-0834
    • Not yet recruiting
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  • Nagoya, Japan, 457-8511
    • Not yet recruiting
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  • Okayama, Japan, 700-8557
    • Withdrawn
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  • Sagamihara-shi, Japan, 252-0315
    • Not yet recruiting
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  • Sapporo, Japan, 060-0001
    • Withdrawn
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  • Sasebo-shi, Japan, 857-1195
    • Recruiting
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  • Sayama-shi, Japan, 350-1305
    • Not yet recruiting
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  • Yokohama, Japan, 236-0037
    • Not yet recruiting
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• Mexico
  • Chihuahua City, Mexico, 31000
    • Not yet recruiting
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  • Estado de México, Mexico, 50090
    • Not yet recruiting
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  • Guadalajara, Mexico, 44160
    • Not yet recruiting
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  • Guadalajara, Mexico, 44650
    • Not yet recruiting
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  • Guadalajara, Mexico, 44690
    • Not yet recruiting
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  • Gustavo A. Madero, Mexico, 07300
    • Not yet recruiting
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  • Mexicali, Mexico, 021100
    • Not yet recruiting
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  • Mexico City, Mexico, 06700
    • Not yet recruiting
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  • Monterrey, Mexico, 64460
    • Not yet recruiting
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  • Mérida, Mexico, 97070
    • Not yet recruiting
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  • San Luis Potosí City, Mexico, 78213
    • Withdrawn
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• Poland
  • Krakow, Poland, 30-727
    • Not yet recruiting
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  • Krakow, Poland, 30-002
    • Not yet recruiting
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  • Torun, Poland, 87-100
    • Not yet recruiting
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  • Warsaw, Poland, 00-874
    • Not yet recruiting
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  • Wroclaw, Poland, 50-244
    • Not yet recruiting
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• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Not yet recruiting
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• South Africa
  • Brackenfell, South Africa, 7560
    • Not yet recruiting
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  • Cape Town, South Africa, 7500
    • Not yet recruiting
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  • Durban, South Africa, 4319
    • Not yet recruiting
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  • Pinelands, South Africa, 7405
    • Not yet recruiting
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  • Pretoria, South Africa, 0002
    • Not yet recruiting
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  • Pretoria, South Africa
    • Not yet recruiting
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  • Somerset West, South Africa, 7130
    • Not yet recruiting
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• Spain
  • Barcelona, Spain, 08035
    • Not yet recruiting
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  • Barcelona, Spain, 08003
    • Not yet recruiting
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  • Barcelona, Spain, 08041
    • Not yet recruiting
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  • Málaga, Spain, 29009
    • Not yet recruiting
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  • Sabadell, Spain, 08208
    • Not yet recruiting
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  • Santiago de Compostela, Spain, 15706
    • Not yet recruiting
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  • Valencia, Spain, 46026
    • Not yet recruiting
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• Ukraine
  • Ivano-Frankivsk, Ukraine, 76018
    • Recruiting
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  • Kyiv, Ukraine, 04050
    • Recruiting
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  • Kyiv, Ukraine, 03037
    • Recruiting
    • Research Site
  • Kyiv, Ukraine, 04210
    • Recruiting
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  • Kyiv, Ukraine, 02002
    • Recruiting
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  • Kyiv, Ukraine, 03049
    • Recruiting
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  • Uzhhorod, Ukraine, 88000
    • Recruiting
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  • Vinnytsia, Ukraine, 21029
    • Recruiting
    • Research Site
  • Vinnytsia, Ukraine, 21018
    • Recruiting
    • Research Site
• United Kingdom
  • Glasgow, United Kingdom, G31 2ER
    • Recruiting
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  • Leeds, United Kingdom, LS7 4SA
    • Recruiting
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  • Luton, United Kingdom, LU4 0DZ
    • Not yet recruiting
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  • Staffordshire, United Kingdom, WS11 5XY
    • Not yet recruiting
    • Research Site
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Not yet recruiting
      • Research Site
    • Prescott Valley, Arizona, United States, 86314
      • Withdrawn
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    • Tucson, Arizona, United States, 85748
      • Not yet recruiting
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  • California
    • La Jolla, California, United States, 92037
      • Not yet recruiting
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    • San Dimas, California, United States, 91773
      • Withdrawn
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    • San Leandro, California, United States, 94578
      • Not yet recruiting
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  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
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  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Withdrawn
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    • Jacksonville, Florida, United States, 32216
      • Withdrawn
      • Research Site
    • South Miami, Florida, United States, 33143
      • Recruiting
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    • Tampa, Florida, United States, 33607
      • Withdrawn
      • Research Site
    • Winter Haven, Florida, United States, 33880
      • Not yet recruiting
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  • Georgia
    • Marietta, Georgia, United States, 30060
      • Not yet recruiting
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  • Illinois
    • Skokie, Illinois, United States, 60076
      • Not yet recruiting
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    • Willowbrook, Illinois, United States, 60527
      • Recruiting
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  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Not yet recruiting
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  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Not yet recruiting
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  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • Recruiting
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  • Missouri
    • Kansas City, Missouri, United States, 64151
      • Not yet recruiting
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    • St Louis, Missouri, United States, 63131
      • Not yet recruiting
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  • Nevada
    • Henderson, Nevada, United States, 89052
      • Recruiting
      • Research Site
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Not yet recruiting
      • Research Site
  • Texas
    • Austin, Texas, United States, 78745
      • Recruiting
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    • Baytown, Texas, United States, 77521
      • Recruiting
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    • Houston, Texas, United States, 77089
      • Recruiting
      • Research Site
    • Houston, Texas, United States, 77027
      • Not yet recruiting
      • Research Site
    • Mesquite, Texas, United States, 75150
      • Not yet recruiting
      • Research Site
    • Tomball, Texas, United States, 77375
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: AZD1163; Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) 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.	Drug: AZD1163; Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) 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.	Drug: AZD1163; Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) 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.	Other: Placebo; Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12	Proportion of participants achieving a 20% improvement in ACR response criteria at Week 12.	Week 12
Percentage of Participants Achieving ACR50 at Week 12	Proportion of participants achieving a 50% improvement in ACR response criteria at Week 12.	Week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12	Change from baseline in CDAI at Week 12.	Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12	Change from baseline in SDAI at Week 12.	Week 12
Summary statistics to evaluate the PK of AZD1163	AZD1163 concentrations in serum	Week 0 to Week 24 and Follow-Up
Summary statistics to evaluate the immunogenicity of AZD1163	ADA (incidence, prevalence, and titres)	Week 0 to Week 24 and Follow-Up

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): August 18, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; placebo-controlled; double-blind; csDMARDs; TNFi; AZD1163; PAD2/4 inhibitor
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: D9640C00003; 2025-522076-85 (Other Identifier: EU CT number); 167070 (Registry Identifier: IND)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No