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

NCT07013110 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: dnaJP1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rheumatoid Arthritis; Rheumatology; dnaJP1; Immune Tolerance

Outcome Measures

Primary Outcomes (4)

• To estimate effect size needed to ascertain the power i.e. the number of patients to be tested in the future study to prove superiority of the combination dnaJP1 and HCQ versus placebo and HCQ - To determine this ACR20 will be employed

  An American College of Rheumatology (ACR) 20% response (ACR20) response was defined as at least 20% improvement in both the tender joint count and the swollen joint count and at least 20% improvement in 3 of the 5 other core set measures listed below. The core set required the inclusion of 7 clinical end points for all RA trials: swollen joint count, tender joint count, physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, and patient's assessment of physical function, and levels of an acute-phase reactant (either the C-reactive protein \[CRP\] level or the erythrocyte sedimentation rate \[ESR\]).

  At Study End being 7 Months

• A primary endpoint of the study will be to determine safety and tolerability of the experimental treatment in terms of AEs, SAEs, TEAEs

  Reporting of Adverse Events

  At Study End being 7 Months

• A mechanistic predictor of clinical efficacy at enrolment before first dosing related to immune changes in the cell activation

  A combination of high dimensionality technologies will be employed, which will include single cell proteomics, a single cell RNA SEQ flow cytometry and mechanistic studies in vitro

  At Study End being 7 Months

• A mechanistic biomarker of treatment response based on 20% change from baseline in increase in Tregs and decrease in inflammatory T cells

  Immunological analysis performed on patients samples

  At Study End being 7 Months

Secondary Outcomes (6)

• To estimate the effect size needed to ascertain the power i.e. the number of patients to be tested in the future study to prove superiority of the combination dnaJP1 and HCQ versus placebo and HCQ - ACR50

  At Study End being 7 Months

• To estimate the effect size needed to ascertain the power i.e. the number of patients to be tested in the future study to prove superiority of the combination dnaJP1 and HCQ versus placebo and HCQ - ACR70

  At Study End being 7 Months

• To estimate the effect size needed to ascertain the power i.e. the number of patients to be tested in the future study to prove superiority of the combination dnaJP1 and HCQ versus placebo and HCQ - DAS28-ESR

  At Study End being 7 Months

• To estimate the effect size needed to ascertain the power i.e. the number of patients to be tested in the future study to prove superiority of the combination dnaJP1 and HCQ versus placebo and HCQ - DAS28-hsCRP

  At Study End being 7 Months

• To estimate the effect size needed to ascertain the power i.e. the number of patients to be tested in the future study to prove superiority of the combination dnaJP1 and HCQ versus placebo and HCQ - Clinical Disease Activity Index (CDAI) Score

  At Study End being 7 Months

Study Arms (2)

dnaJP1

EXPERIMENTAL

dnaJP1 peptide 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach.

Drug: dnaJP1

Control

PLACEBO COMPARATOR

Placebo 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach.

Drug: Placebo

Interventions

dnaJP1 DRUG

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.

dnaJP1

Placebo DRUG

This is the control.

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of rheumatoid arthritis (RA) based on 2010 ACR/EULAR classification criteria
• DAS28-ESR score more than 3.2 (at least moderately active)
• Male or female with age 21 or above
• Ability to understand and sign informed consent
• Agree to use acceptable methods of contraception for e.g. oral contraceptive pills, implanted contraception, barrier methods, and intra-uterine devices
• Allowed used of oral Prednisone up to 10 mg/day and NSAIDs, as prescribed by the treating physician
• Able and willing to comply with the protocol, including availability for all scheduled study visits and assessments.
• Using the 2010 ACR/EULAR classification criteria for RA, classification as definite RA is based upon the presence of synovitis in at least one joint, the absence of an alternative diagnosis that better explains the synovitis, and the achievement of a total score of at least 6 (of a possible 10) from the individual scores in four domains. The highest score achieved in a given domain is used for this calculation. These domains and their values are:
• Number and site of involved joints:
• to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
• to 3 small joints (from among the metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) = 2 points
• to 10 small joints = 3 points
• Greater than 10 joints (including at least 1 small joint) = 5 points
• Serological abnormality (rheumatoid factor or anti-citrullinated peptide/protein antibody)
• Low positive (above the upper limit of normal \[ULN\]) = 2 points

You may not qualify if:

• On prednisolone \>10 mg daily
• History of receiving:
• conventional synthetic (cs-) disease modifying anti-rheumatic drugs (DMARDs) such as sulfasalazine, methotrexate, and leflunomide administered 6 months prior to screening
• . biological (b-) DMARDs such as rituximab, infliximab, tocilizumab, adalimumab, etc.
• tissue-specific (tsp.-) DMARDs such as JAK inhibitors
• History of lymphoma
• Active malignancy requiring treatment the last 5 years except for non-melanoma skin cancers and carcinoma of the cervix in situ
• Pregnancy
• Breast-feeding
• Active Infection, e.g., Hepatitis B, tuberculosis
• A known hypersensitivity to dnaJP1 or to any of the excipients
• Significant cardiac history, e.g., have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
• A history or presence of dermatological, cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, haematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking HCQ and/or the investigational product or could interfere with the interpretation of data
• An eGFR based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \<40 ml/min/1.73 m2
• A history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin 1.5 times the ULN

Sponsors & Collaborators

• Prof Salvatore Albani: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Salvatore Albani, MD PhD

  Singapore Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvatore Albani, MD PhD

CONTACT

+65 6576 7179; salvo@duke-nus.edu.sg

Grace Compton-Tan

CONTACT

+65 6576 7185

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, SingHealth Translational Immunology and Inflammation Centre (STIIC)

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 10, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)