RecruitingPhase 2NCT07013110

An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis

An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis - A Double-blind, Randomized, Placebo-controlled Clinical Trial

Sponsor

Prof Salvatore Albani

Enrollment

124 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis (RA)Rheumatology

Summary

This clinical study is a multi-center, randomized, double-blind, placebo-controlled, outpatient study comparing the efficacy of combination of dnaJP1 peptide and hydroxychloroquine versus combination of placebo and hydroxychloroquine in patients with moderately to severely active RA who are naive to cs-, b-, tsp.-DMARDs. A sample size of 124 patients will be enrolled in the study. Each patient will receive either combination of dnaJP1 peptide and hydroxychloroquine or combination of placebo and hydroxychloroquine in 1:1 allocation ratio.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an AI-powered approach to match people with rheumatoid arthritis (RA) to the immunotherapy drug that is most likely to work for them — rather than using trial and error, which is how RA treatment often works today. **You may be eligible if...** - You are 21 or older and have been diagnosed with rheumatoid arthritis based on established criteria - Your RA is at least moderately active (DAS28-ESR score above 3.2) - You are willing to use a reliable form of contraception during the study - Low-dose prednisone (up to 10 mg/day) and anti-inflammatory drugs are allowed if already prescribed **You may NOT be eligible if...** - You have a serious infection or immune system condition other than RA - You have significant kidney, liver, or heart problems - You are pregnant or planning to become pregnant during the study - You have had a serious reaction to biologic medications in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdnaJP1

The study drug is dnaJP1 peptide. It is a manmade short protein that can be taken easily as a pill. dnaJP1 works to restore the body's immune tolerance by improving its ability to self-adjust - helps to restore the immune system and improve controls on inflammation that has been lost.

DRUGPlacebo

This is the control.