AZD1163 for Rheumatoid Arthritis
(LaunchPAD-RA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD1163 to determine its safety and effectiveness for people with rheumatoid arthritis (RA), a condition that causes joint pain and swelling. Participants will receive one of three different doses of AZD1163 or a placebo, along with standard treatments, to evaluate its effectiveness over 24 weeks. The trial seeks individuals who have experienced moderate to severe RA for at least 12 weeks and have not found success with other RA treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose of a csDMARD or SC TNFi for at least 4 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AZD1163 is being tested for safety and effectiveness in people with rheumatoid arthritis. Studies with healthy participants have tested AZD1163 both intravenously and subcutaneously. These studies indicate that the treatment is generally well-tolerated, with no major safety concerns reported. In another study with animals, AZD1163 also demonstrated a good safety profile.
While AZD1163 is still under investigation, early results suggest it is safe enough to proceed with human trials. However, as with any new treatment, potential side effects remain a focus for researchers. If considering joining a trial, the research team will provide detailed information about any known risks.12345Why are researchers excited about this trial's treatment for RA?
Researchers are excited about AZD1163 for rheumatoid arthritis because it offers a potentially new approach to treatment. Unlike traditional options like methotrexate or TNF inhibitors, which primarily focus on reducing inflammation, AZD1163 might work differently by targeting specific pathways involved in the disease process. This treatment is delivered via subcutaneous injection, which could offer convenience and better patient compliance. The idea that AZD1163 might provide relief in a novel way keeps researchers hopeful for improved outcomes for patients with rheumatoid arthritis.
What evidence suggests that AZD1163 could be an effective treatment for rheumatoid arthritis?
Research has shown that AZD1163 might effectively treat rheumatoid arthritis (RA). AZD1163 is a new medication targeting specific enzymes called PAD2/4, which help produce substances contributing to RA. Early findings suggest that AZD1163 can block these enzymes, with higher doses potentially working better. This trial will test different doses of AZD1163 to determine their effectiveness. Initial studies have shown promise in improving outcomes for RA patients by addressing these underlying causes.13678
Are You a Good Fit for This Trial?
This trial is for adults with moderately-to-severely active rheumatoid arthritis (RA) diagnosed at least 12 weeks prior. Participants must have had an inadequate response or intolerance to certain RA treatments and be on a stable dose of csDMARDs or TNFi. Those with other autoimmune conditions that could affect RA diagnosis, except secondary Sjogren's disease, can't join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomisation
Participants are randomised to receive one of three doses of AZD1163 or placebo
Treatment
Participants receive subcutaneous injections of AZD1163 or placebo in combination with standard of care until Week 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD1163
Trial Overview
The study is testing the effectiveness and safety of AZD1163 in individuals with active rheumatoid arthritis compared to a placebo. It's a Phase II trial where participants will either receive the investigational drug AZD1163 or a placebo without knowing which one they are getting.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
A Study to Investigate Efficacy and Safety of AZD1163 in ...
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163. Detailed ...
AZD1163 Phase I Study | EULAR 2024
AZD1163 holds promise for improving clinical outcomes and addressing the underlying mechanisms of rheumatoid arthritis pathology.
AZD1163, a Novel Bispecific Human Antibody Targeting ...
AZD1163, a Novel Bispecific Human Antibody Targeting PAD2/4 Enzymes Responsible for Generating Citrullinated Protein Auto-antigens in Rheumatoid Arthritis, ...
AZD1163 / AstraZeneca
LaunchPAD-RA: A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=320 | Not yet ...
Study Details | NCT06103877 | A Placebo-controlled ...
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
OP0110 AZD1163 - FIRST-IN-CLASS ANTI-PAD2/4 BI- ...
Single and multi-dose studies in non-human primates were used to evaluate the pharmacokinetics, pharmacodynamics and safety profile of this novel antibody.
AZD 1163 - AdisInsight - Springer
AZD 1163, a bispecific antibody inhibitor of PAD2 (protein-arginine deiminase type 2) and PAD4 (protein-arginine deiminase type 4), being developed by.
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-investigate-efficacy-and-safety-of-azd1163-in-participants-with-rheumatoid-arthritisA Study to Investigate Efficacy and Safety of AZD1163 in ...
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
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