A Phase 2 interventional study of dnaJP1 and Placebo in Rheumatoid Arthritis (RA) and Rheumatology, sponsored by Prof Salvatore Albani. Recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Prof Salvatore Albani · Phase 2, Interventional, and Treatment
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.
Despite the availability of a plethora of new drugs to treat Rheumatoid Arthritis (RA), a holistic and accurate understanding of how therapy with biologics works is still missing. The knowledge gap is particularly poignant if one considers that the second-generation drugs developed for immune therapy is still entirely suppressive. Thus, the dramatic advances in molecular immunology has yet to be translated into the needed evolution from immune suppression to true immune tolerization, an important step on the evolutionary pathway from therapy to cure.
This study is designed to be a multi-center, randomized, double-blind, placebo-controlled trial which has two fundamental objectives:
To identify and dissect mechanisms of induction of immune tolerance in RA patients in response to immune therapy with dnaJP1, a microbiome-derived peptide. Tangibly in the context of clinical development, the investigators aim to capitalize on this knowledge to identify and validate biomarkers predictor of efficacy and clinical response;
The investigators will also determine the effect size needed to demonstrate whether the combination of dnaJP1 peptide and hydroxychloroquine (HCQ) is superior to the combination of placebo and hydroxychloroquine in the treatment of patients with moderately to severely active RA naïve to disease modifying anti-rheumatic drugs (i.e. DMARDs and biologics-naïve).
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 124 is above the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →This is the only study on the registry with Prof Salvatore Albani as lead sponsor.
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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:
Serological abnormality (rheumatoid factor or anti-citrullinated peptide/protein antibody)
Exclusion Criteria:
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.
dnaJP1 peptide 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach.
Drug: dnaJP1
Placebo 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach.
Drug: Placebo
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.
This is the control.
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 \[ESR\]).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 - ACR50
The American College of Rheumatology (ACR) 50% response (ACR50) response is the same instruments with improvement levels defined as 50% versus 20% for ACR20
Time frame: 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
The American College of Rheumatology (ACR) 70% response (ACR70) response is the same instruments with improvement levels defined as 70% versus 20% for ACR20
Time frame: 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
Disease Activity Score-28 for Rheumatoid Arthritis with erythrocyte sedimentation rate (DAS28- ESR) describes severity of rheumatoid arthritis using clinical and laboratory data, specifically ESR. The number "28" describes the number of different joints examined in the assessment. The DAS-ESR values range from 2.0 to 10.0 while higher values indicate higher disease activity. A DAS28-ESR score of ≤ 2.6 indicates remission or ≤ 3.2 indicates low disease activity.
Time frame: 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
Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) is a modification of the DAS28-ESR, DAS28-CRP uses the C-Reactive Protein (CRP) value instead of erythrocyte sedimentation rate (ESR). The DAS28-CRP values range from 2.0 to 10.0 while higher values indicate higher disease activity.
Time frame: 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
The CDAI is a composite index (without acute-phase reactant) for assessing disease activity. CDAI score is based on the simple summation of the count of swollen/tender joint count of 28 joints along with patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI score ranges from 0 to 76. A CDAI score of ≤ 2.8 indicates remission of disease.
Time frame: 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 - Simplified Disease Activity Index (SDAI)
The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity \[visual analogue scale (VAS) 0-10 cm\] and level of C-reactive protein (mg/dl, normal \<1 mg/dl). A SDAI score of ≤ 3.3 indicates remission of disease.
Time frame: At Study End being 7 Months
Plan to share: No
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