Phase 2 Rheumatoid Arthritis Trial, Recruiting NCT07013110 Sponsor: Prof Salvatore Albani Condition: Rheumatoid Arthritis
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Phase 2 Rheumatoid Arthritis Trial, Recruiting

NCT07013110
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with rheumatoid arthritis (RA) according to a standard set of medical classification guidelines
  • People whose RA is at least moderately active, based on a disease activity score measured by a doctor
  • People aged 21 or older, of any gender
  • People who are able to understand the study information and agree in writing to take part
  • People who are willing to use an accepted form of contraception during the trial, such as the pill, an implant, a barrier method, or an IUD
  • People who are currently taking low-dose steroid tablets (prednisone up to 10 mg per day) and/or anti-inflammatory pain relief, if prescribed by their treating doctor
  • People who are able and willing to attend all required study visits and follow the study schedule

Who may not be able to join:

  • People taking prednisolone at a dose higher than 10 mg per day
  • People who have taken certain arthritis medications in the past — including disease-modifying drugs such as methotrexate, sulfasalazine, or leflunomide in the last 6 months, or biological treatments such as rituximab, infliximab, adalimumab, or tocilizumab at any time, or a type of medication called JAK inhibitors at any time
  • People with a history of lymphoma (a type of blood cancer)
  • People who have had an active cancer requiring treatment in the last 5 years (exceptions may apply for certain skin cancers and a specific type of early cervical condition — confirm with trial site)
  • People who are currently pregnant
  • People who are currently breastfeeding
  • People with an active infection, such as Hepatitis B or tuberculosis
  • People with a known allergy or sensitivity to the study drug (dnaJP1) or any of its ingredients
  • People who have had a heart attack, unstable heart disease, stroke, or severe heart failure within the 12 weeks before entering the study
  • People with significant ongoing conditions affecting the skin, heart, lungs, liver, digestive system, hormones, blood, nervous system, or mental health that a doctor considers could pose a risk or affect study results (confirm with trial site)
  • People whose kidneys are not functioning well enough, based on a specific blood test result falling below a set level (confirm with trial site)
  • People with a history of chronic liver disease, or whose most recent liver blood test results are above a certain level (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Salvatore Albani, MD PhD, Singapore Health Services

Phone: +65 6576 7179

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Prof Salvatore Albani
Registry
ClinicalTrials.gov
Start date
18 June 2025
Est. completion
1 November 2028

Where this trial is recruiting

🇸🇬 Singapore

Primary endpoints

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; A primary endpoint of the study will be to determine safety and tolerability of the experimental treatment in terms of AEs, SAEs, TEAEs; A mechanistic predictor of clinical efficacy at enrolment before first dosing related to immune changes in the cell activation; A mechanistic biomarker of treatment response based on 20% change from baseline in increase in Tre...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov