Rheumatoid Arthritis (RA)Phase 2dnaJP1NCT07013110
An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis
A Phase 2 study testing dnaJP1 in people with Rheumatoid Arthritis (RA) and Rheumatology, run by Prof Salvatore Albani at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Rheumatology
- What is being tested?
- dnaJP1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Jun 2025to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- 2 to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
- 1 to 3 small joints (from among the metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists) = 2 points
- 4 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
- High positive (greater than three times the ULN) = 3 points
- Elevated acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) above the ULN = 1 point
- Symptom duration at least six weeks = 1 point
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Grace Compton-Tan contact
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Chin Teck NG, MD, +65 6321 4028, ng.chin.teck@singhealth.com.sg
About this study
Official title: An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis - A Double-blind, Randomized, Placebo-controlled Clinical Trial
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.
Read the detailed description
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).
- Conditions
- Rheumatoid Arthritis (RA), Rheumatology
- Being tested
- dnaJP1, Placebo
- Keywords
- Rheumatoid Arthritis, Rheumatology, dnaJP1, Immune Tolerance
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dnaJP1Drug
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.
PlaceboDrug
This is the control.
| Study group | Role | What they receive |
|---|---|---|
| dnaJP1 | Experimental | dnaJP1 peptide 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach. Receives: Drug: dnaJP1 |
| Control | Placebo comparator | Placebo 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The American College of Rheumatology (ACR) 50% response (ACR50) response is the same instruments with improvement levels defined as 50% versus 20% for ACR20
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Study End being 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start18 Jun 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Salvatore Albani
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor-investigator, Prof Salvatore Albani, Singapore Health Services
- Investigators
- Salvatore Albani, MD PhD, Principal investigator, Singapore Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013110
- Sponsor's protocol ID
- dnaJP1
- Acronym
- dnaJP1
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence-powered Approach to Precision Immunotherapy of Human Arthritis - A Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07013110
- Acronym / sponsor ID
- dnaJP1 / dnaJP1
- Conditions
- Rheumatoid Arthritis (RA), Rheumatology
- Keywords
- Rheumatoid Arthritis, Rheumatology, dnaJP1, Immune Tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Prof Salvatore AlbaniUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dnaJP1 | Experimental | Drug: dnaJP1dnaJP1 peptide 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach. |
| Control | Placebo comparator | Drug: PlaceboPlacebo 25mg with Hydroxychloroquine (HCQ) 200mg once daily are administered orally, preferably in the morning on an empty stomach. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (15 listed)
- On prednisolone >10 mg daily
- History of receiving:
- •. biological (b-) DMARDs such as rituximab, infliximab, tocilizumab, adalimumab, etc.
- History of lymphoma
- Active malignancy requiring treatment the last 5 years except for non-melanoma skin cancers and carcinoma of the cervix in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dnaJP1The 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 | dnaJP1 |
| PlaceboThis is the control. | Drug | Control |
Primary outcome
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
Time frame: At Study End being 7 Months
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]).
A primary endpoint of the study will be to determine safety and tolerability of the experimental treatment in terms of AEs, SAEs, TEAEs
Time frame: At Study End being 7 Months
Reporting of Adverse Events
A mechanistic predictor of clinical efficacy at enrolment before first dosing related to immune changes in the cell activation
Time frame: At Study End being 7 Months
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
A mechanistic biomarker of treatment response based on 20% change from baseline in increase in Tregs and decrease in inflammatory T cells
Time frame: At Study End being 7 Months
Immunological analysis performed on patients samples
6 secondary outcomes
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
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
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
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
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
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)
Time frame: At Study End being 7 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace Compton-Tan contact
Salvatore Albani, MD PhD principal investigator
Singapore Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dnaJP1 in people with Rheumatoid Arthritis (RA) and Rheumatology, run by Prof Salvatore Albani at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Albani, MD PhD (+65 6576 7179, salvo@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At Study End being 7 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.