AzTrials
AzTrials

Rheumatoid ArthritisPhase 2LaunchPAD-RANCT07276581

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

A Phase 2 study testing AZD1163 in people with Rheumatoid Arthritis, run by AstraZeneca at 147 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
AZD1163
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
147 sitesin 17 countries
Study dates
15 Dec 2025to 18 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

147 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

147 sites in 17 countries

United States29 sites, 23 recruiting
  • Research Site

    Aurora, Colorado, 80045

    Recruiting
  • Research Site

    Austin, Texas, 78745

    Recruiting
  • Research Site

    Baltimore, Maryland, 21224

    Recruiting
  • Research Site

    Baytown, Texas, 77521

    Recruiting
  • Research Site

    Boynton Beach, Florida, 33435

    Withdrawn
  • Research Site

    Glendale, Arizona, 85306

    Recruiting
  • Research Site

    Henderson, Nevada, 89052

    Recruiting
  • Research Site

    Houston, Texas, 77027

    Recruiting
  • Research Site

    Houston, Texas, 77089

    Recruiting
  • Research Site

    Jacksonville, Florida, 32216

    Withdrawn
  • Research Site

    Kansas City, Missouri, 64151

    Recruiting
  • Research Site

    La Jolla, California, 92037

    Recruiting
  • Research Site

    Lake Charles, Louisiana, 70605

    Recruiting
  • Research Site

    Marietta, Georgia, 30060

    Recruiting
  • Research Site

    Mesquite, Texas, 75150

    Recruiting
  • Research Site

    Myrtle Beach, South Carolina, 29572

    Recruiting
  • Research Site

    New Bedford, Massachusetts, 02740

    Recruiting
  • Research Site

    Prescott Valley, Arizona, 86314

    Withdrawn
  • Research Site

    Rockville, Maryland, 20850

    Not yet recruiting
  • Research Site

    San Dimas, California, 91773

    Withdrawn
  • Research Site

    San Leandro, California, 94578

    Recruiting
  • Research Site

    Skokie, Illinois, 60076

    Recruiting
  • Research Site

    South Miami, Florida, 33143

    Suspended
  • Research Site

    St Louis, Missouri, 63131

    Recruiting
  • Research Site

    Tampa, Florida, 33607

    Withdrawn
  • Research Site

    Tomball, Texas, 77375

    Recruiting
  • Research Site

    Tucson, Arizona, 85748

    Recruiting
  • Research Site

    Willowbrook, Illinois, 60527

    Recruiting
  • Research Site

    Winter Haven, Florida, 33880

    Recruiting

Other trials in United States

Japan17 sites, 15 recruiting
  • Research Site

    Aomori, 030-8553

    Recruiting
  • Research Site

    Bunkyō City, 113-8655

    Recruiting
  • Research Site

    Fukuoka, 815-8555

    Recruiting
  • Research Site

    Hamamatsu, 430-0906

    Recruiting
  • Research Site

    Hitachi-Naka, 312-0057

    Recruiting
  • Research Site

    Iizuka-shi, 820-8505

    Recruiting
  • Research Site

    Kawachinagano-shi, 586-8521

    Recruiting
  • Research Site

    Matsuyama, 790-8524

    Recruiting
  • Research Site

    Meguro-ku, 152-8902

    Recruiting
  • Research Site

    Miyazaki, 880-0834

    Recruiting
  • Research Site

    Nagoya, 457-8511

    Recruiting
  • Research Site

    Okayama, 700-8557

    Withdrawn
  • Research Site

    Sagamihara-shi, 252-0315

    Recruiting
  • Research Site

    Sapporo, 060-0001

    Withdrawn
  • Research Site

    Sasebo-shi, 857-1195

    Recruiting
  • Research Site

    Sayama-shi, 350-1305

    Recruiting
  • Research Site

    Yokohama, 236-0037

    Recruiting

Other trials in Japan

China15 sites, 15 recruiting
  • Research Site

    Beijing, 100144

    Recruiting
  • Research Site

    Beijing, 100730

    Recruiting
  • Research Site

    Changchun, 130021

    Recruiting
  • Research Site

    Changsha, 410008

    Recruiting
  • Research Site

    Guangzhou, 510515

    Recruiting
  • Research Site

    Jiujiang, 332000

    Recruiting
  • Research Site

    Kunming, 650032

    Not yet recruiting
  • Research Site

    Linyi, CN-276003

    Recruiting
  • Research Site

    Nanchong, 637000

    Recruiting
  • Research Site

    Panjin, 124000

    Recruiting
  • Research Site

    Pingxiang, 337055

    Recruiting
  • Research Site

    Shantou, 515041

    Recruiting
  • Research Site

    Xuzhou, 221009

    Recruiting
  • Research Site

    Yangzhou, 225001

    Recruiting
  • Research Site

    Zhengzhou, 450000

    Recruiting

Other trials in China

Mexico11 sites, 10 recruiting
  • Research Site

    Chihuahua City, 31000

    Recruiting
  • Research Site

    Estado de México, 50090

    Not yet recruiting
  • Research Site

    Guadalajara, 44160

    Not yet recruiting
  • Research Site

    Guadalajara, 44650

    Not yet recruiting
  • Research Site

    Guadalajara, 44690

    Not yet recruiting
  • Research Site

    Gustavo A. Madero, 07300

    Not yet recruiting
  • Research Site

    Mérida, 97070

    Not yet recruiting
  • Research Site

    Mexicali, 021100

    Not yet recruiting
  • Research Site

    Mexico City, 06700

    Recruiting
  • Research Site

    Monterrey, 64460

    Not yet recruiting
  • Research Site

    San Luis Potosí City, 78213

    Withdrawn

Other trials in Mexico

Ukraine9 sites, 9 recruiting
  • Research Site

    Ivano-Frankivsk, 76018

    Recruiting
  • Research Site

    Kyiv, 02002

    Recruiting
  • Research Site

    Kyiv, 03037

    Recruiting
  • Research Site

    Kyiv, 03049

    Recruiting
  • Research Site

    Kyiv, 04050

    Recruiting
  • Research Site

    Kyiv, 04210

    Recruiting
  • Research Site

    Uzhhorod, 88000

    Recruiting
  • Research Site

    Vinnytsia, 21018

    Recruiting
  • Research Site

    Vinnytsia, 21029

    Recruiting

Other trials in Ukraine

Hungary8 sites, 8 recruiting
  • Research Site

    Budapest, 1023

    Recruiting
  • Research Site

    Budapest, 1027

    Recruiting
  • Research Site

    Budapest, 1036

    Not yet recruiting
  • Research Site

    Debrecen, 4032

    Recruiting
  • Research Site

    Gyula, 5700

    Recruiting
  • Research Site

    Szeged, 6725

    Recruiting
  • Research Site

    Székesfehérvár, 8000

    Recruiting
  • Research Site

    Veszprém, 8200

    Recruiting

Other trials in Hungary

Brazil7 sites, 6 recruiting
  • Research Site

    Juiz de Fora, 36010 570

    Not yet recruiting
  • Research Site

    Pelotas, 96040-010

    Recruiting
  • Research Site

    Porto Alegre, 90035-903

    Recruiting
  • Research Site

    Porto Alegre, 9061-000

    Recruiting
  • Research Site

    Salvador, 41820-020

    Recruiting
  • Research Site

    São Paulo, 04266-010

    Withdrawn
  • Research Site

    São Paulo, 05403-000

    Not yet recruiting

Other trials in Brazil

Chile7 sites, 6 recruiting
  • Research Site

    Providencia, 7510186

    Withdrawn
  • Research Site

    Santiago, 7500571

    Recruiting
  • Research Site

    Santiago, 7500587

    Recruiting
  • Research Site

    Temuco, 4810345

    Recruiting
  • Research Site

    Valdivia, 5110683

    Recruiting
  • Research Site

    Victoria, 4720097

    Recruiting
  • Research Site

    Viña del Mar, 2531172

    Recruiting

Other trials in Chile

South Africa7 sites, 6 recruiting
  • Research Site

    Brackenfell, 7560

    Withdrawn
  • Research Site

    Cape Town, 7500

    Recruiting
  • Research Site

    Durban, 4319

    Recruiting
  • Research Site

    Pinelands, 7405

    Recruiting
  • Research Site

    Pretoria, 0002

    Recruiting
  • Research Site

    Pretoria, 0083

    Not yet recruiting
  • Research Site

    Somerset West, 7130

    Recruiting

Other trials in South Africa

Spain7 sites, 7 recruiting
  • Research Site

    Barcelona, 08003

    Recruiting
  • Research Site

    Barcelona, 08035

    Recruiting
  • Research Site

    Barcelona, 08041

    Recruiting
  • Research Site

    Málaga, 29009

    Recruiting
  • Research Site

    Sabadell, 08208

    Recruiting
  • Research Site

    Santiago de Compostela, 15706

    Recruiting
  • Research Site

    Valencia, 46026

    Recruiting

Other trials in Spain

Argentina6 sites, 6 recruiting
  • Research Site

    Caba, C1128AAF

    Recruiting
  • Research Site

    Ciudad de Buenos Aires, C1015ABO

    Recruiting
  • Research Site

    Ciudad de Buenos Aires, C1428DUQ

    Recruiting
  • Research Site

    Córdoba, X5000EDC

    Recruiting
  • Research Site

    San Isidro, 1643

    Recruiting
  • Research Site

    San Miguel de Tucumán, T4000AXL

    Recruiting

Other trials in Argentina

Bulgaria6 sites, 6 recruiting
  • Research Site

    Haskovo, 6304

    Recruiting
  • Research Site

    Pleven, 5800

    Recruiting
  • Research Site

    Sofia, 1113

    Recruiting
  • Research Site

    Sofia, 1336

    Recruiting
  • Research Site

    Sofia, 1606

    Recruiting
  • Research Site

    Sofia, 1612

    Recruiting

Other trials in Bulgaria

Poland5 sites, 5 recruiting
  • Research Site

    Krakow, 30-002

    Recruiting
  • Research Site

    Krakow, 30-727

    Recruiting
  • Research Site

    Torun, 87-100

    Recruiting
  • Research Site

    Warsaw, 00-874

    Recruiting
  • Research Site

    Wroclaw, 50-244

    Recruiting

Other trials in Poland

Canada4 sites, 4 recruiting
  • Research Site

    Niagara Falls, Ontario, L2E 6A6

    Not yet recruiting
  • Research Site

    Ottawa, Ontario, K1V 1C1

    Not yet recruiting
  • Research Site

    Trois-Rivières, Quebec, G9A 3Y2

    Recruiting
  • Research Site

    Windsor, Ontario, N8X 5A7

    Recruiting

Other trials in Canada

Germany4 sites, 3 recruiting
  • Research Site

    Bad Doberan, 18209

    Withdrawn
  • Research Site

    Berlin, 10777

    Recruiting
  • Research Site

    Hamburg, 20095

    Recruiting
  • Research Site

    Sendenhorst, 48324

    Recruiting

Other trials in Germany

United Kingdom4 sites, 3 recruiting
  • Research Site

    Glasgow, G31 2ER

    Recruiting
  • Research Site

    Leeds, LS7 4SA

    Recruiting
  • Research Site

    Luton, LU4 0DZ

    Recruiting
  • Research Site

    Staffordshire, WS11 5XY

    Withdrawn

Other trials in United Kingdom

Puerto Rico1 site, 1 recruiting
  • Research Site

    Caguas, 00725

    Recruiting

Other trials in Puerto Rico

About this study

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)

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

Read the 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.

Being tested
AZD1163, Placebo
Keywords
Rheumatoid arthritis, AZD1163, placebo-controlled, double-blind, csDMARDs, TNFi, PAD2/4 inhibitor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD1163Drug

    Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

  • PlaceboOther

    Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.

Study groups in NCT07276581
Study groupRoleWhat they receive
AZD1163 Dose 1ExperimentalParticipants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Receives: Drug: AZD1163
AZD1163 Dose 2ExperimentalParticipants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Receives: Drug: AZD1163
AZD1163 Dose 3ExperimentalParticipants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Receives: Drug: AZD1163
PlaceboPlacebo comparatorParticipants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (6)
  1. 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.

    Measured: Week 12

  2. Percentage of Participants Achieving ACR50 at Week 12

    Proportion of participants achieving a 50% improvement in ACR response criteria at Week 12.

    Measured: Week 12

  3. Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12

    Change from baseline in CDAI at Week 12.

    Measured: Week 12

  4. Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12

    Change from baseline in SDAI at Week 12.

    Measured: Week 12

  5. Summary statistics to evaluate the PK of AZD1163

    AZD1163 concentrations in serum

    Measured: Week 0 to Week 24 and Follow-Up

  6. Summary statistics to evaluate the immunogenicity of AZD1163

    ADA (incidence, prevalence, and titres)

    Measured: Week 0 to Week 24 and Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start15 Dec 2025
  3. Primary completion12 Nov 2027 (estimated)
  4. Study completion18 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07276581
Sponsor's protocol ID
D9640C00003
Other IDs
2025-522076-85, 167070, 2025
Acronym
LaunchPAD-RA
Status last verified
Oct 2026
First submitted
1 Dec 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1163 in people with Rheumatoid Arthritis, run by AstraZeneca at 147 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Japan, China, Mexico, Ukraine and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in