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

NCT07013110 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-08-11

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)
  • Rheumatology

Interventions

DRUG

dnaJP1

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.

DRUG

Placebo

This is the control.

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER

  • Prof Salvatore Albani

    lead OTHER

Principal Investigators

  • Salvatore Albani, MD PhD · Singapore Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013110 on ClinicalTrials.gov