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Rheumatoid ArthritisPhase 2NCT07779616

Study of PTC844 in Participants With Active Rheumatoid Arthritis

A Phase 2 study testing PTC844 in people with Rheumatoid Arthritis, run by PTC Therapeutics at 26 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
PTC844
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
26 sitesin 4 countries
Study dates
24 Sep 2026to 29 Oct 2027
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria.
  • Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at screening.
  • Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and/or inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion.
  • Disease-modifying antirheumatic drugs should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study.
  • CRP of ≥5 milligrams (mg)/liter (L) at screening.

Who cannot join

  • Presence of any clinically significant abnormality at screening, or prior or ongoing medical condition (for example, concomitant illness, psychiatric condition), surgical procedure, medical history, or physical findings that, in the investigator's opinion, could adversely affect the safety of the participant or could impair the assessment of study results.
  • Participants with Class IV RA.
  • Past medical history of blood dyscrasia, bone marrow abnormality and/or suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis.
  • Past medical history of inflammatory joint disease other than RA or fibromyalgia.
  • Rheumatoid arthritis onset at <17 years of age.
  • Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection.
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  • Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug.
  • Use or intended use of any prescribed disease-modifying treatments for RA within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit, except for methotrexate, low dose prednisone (<10 mg/day), hydroxychloroquine, or sulfasalazine, which are permitted as established background single-therapy medications.
  • Use or intended use of a combination of methotrexate, low dose prednisone (<10 mg/day), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit.
  • Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

26 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Patient Advocacy contact

1-866-562-4620

medinfo@ptcbio.com

26 sites in 4 countries

United States14 sites, 14 recruiting

  • AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Chandler

    Chandler, Arizona, 85210

    Amer Al-Khoudari

    Recruiting

  • DJL Clinical Research PLLC

    Charlotte, North Carolina, 28211

    Jane (Emily) Box

    Not yet recruiting

  • Chicago Arthritis and Regenerative Medicine

    Chicago, Illinois, 60611

    Siddharth Tambar

    Not yet recruiting

  • Nouvelle Clinical Research LLC

    Cutler Bay, Florida, 33189

    Rawan Jumean

    Recruiting

  • Arthritis & Rheumatism Associates - Fairfax

    Fairfax, Virginia, 22031

    Daniel El-Bogdadi

    Not yet recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

    Flagstaff, Arizona, 86001

    Alexander Hu

    Not yet recruiting

  • Precision Comprehensive Clinical Research Solutions - Irving

    Irving, Texas, 76051

    Renuka Basavaraju

    Recruiting

  • Vitaly Clinical Research, LLC

    Miami, Florida, 33125

    Pedro San Martin Parra

    Not yet recruiting

  • Millennium Medical Research, LLC.

    Miami, Florida, 33126

    Ramon Moreda

    Recruiting

  • Suncoast Clinical Research, Inc. - New Port Richey

    New Port Richey, Florida, 34652

    Farrukh Zaidi

    Not yet recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix

    Phoenix, Arizona, 85032

    Nikila Kumar

    Not yet recruiting

  • Millennium Clinical Trials

    Westlake Village, California, 91361

    Tony Makhlouf

    Recruiting

  • Rheumatology Specialty Center

    Willow Grove, Pennsylvania, 19090

    Elana Eisner

    Not yet recruiting

  • Conquest Research

    Winter Park, Florida, 32789

    Anand Patel

    Recruiting

Other trials in United States

Georgia7 sites, 7 recruiting

  • Aversi Clinic LLC

    Tbilisi

    Irine Malazonia

    Not yet recruiting

  • JSC Jerarsi

    Tbilisi

    Rima Akhvlediani

    Not yet recruiting

  • JSC Vian - Iv. Bokeria University Hospital

    Tbilisi

    Rusudan Bibilashvili

    Not yet recruiting

  • JSC VIAN Caraps Medline

    Tbilisi

    Manana Zodelava

    Not yet recruiting

  • LTD Caucasus Medical Centre

    Tbilisi

    Marina Toidze

    Not yet recruiting

  • LTD Innova

    Tbilisi

    Luba Lagvilava

    Not yet recruiting

  • The First Medical Center LLC

    Tbilisi

    Tamta Kobakhidze

    Not yet recruiting

Other trials in Georgia

South Africa4 sites, 4 recruiting

  • Arthritis Clinical Research Trials CC

    Cape Town

    Catherine Spargo

    Not yet recruiting

  • Dr IC Louw

    Cape Town

    CI Louw

    Not yet recruiting

  • Clinresco Centres (Pty) Ltd

    Kempton Park

    Jennifer Rosa

    Not yet recruiting

  • Clinical Trials Network - Helderberg

    Somerset West

    Gareth Tarr

    Not yet recruiting

Other trials in South Africa

Mauritius1 site, 1 recruiting

  • CAP Research ltd

    Quatre Bornes

    Poojdev Jhugroo

    Not yet recruiting

Other trials in Mauritius

About this study

Official title: A Phase 2A, Proof-of-Concept, Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PTC844 in Participants With Active Rheumatoid Arthritis

This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA).

Being tested
PTC844, Placebo
Keywords
Immune-mediated disease, Autoimmune disease, Dihydroorotate dehydrogenase (DHODH) inhibitors, PTC844, Rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTC844Drug

    PTC844 will be administered per schedule specified in the arm description.

  • PlaceboDrug

    Placebo matching to PTC844 will be administered per schedule specified in the arm description.

Study groups in NCT07779616
Study groupRoleWhat they receive
PTC844 Low DoseExperimentalParticipants will receive PTC844 at a low dose once daily (QD) orally for 12 weeks.
Receives: Drug: PTC844
PTC844 High DoseExperimentalParticipants will receive PTC844 at a high dose QD orally for 12 weeks.
Receives: Drug: PTC844
PlaceboPlacebo comparatorParticipants will receive placebo matching to PTC844 QD orally for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Baseline up to Week 16

  2. Change From Baseline to Week 2 in Dihydroorotate (DHO)

    Measured: Baseline, Week 2

Secondary outcomes (12)

  1. Change From Baseline to Week 12 in C-reactive Protein (CRP)

    Measured: Baseline, Week 12

  2. Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)

    Measured: Baseline, Week 12

  3. Change From Baseline in DHO Over Time

    Measured: Baseline up to Week 16

  4. Maximum Observed Plasma Concentration (Cmax) of PTC844

    Measured: Baseline up to Week 16

  5. Area Under the Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast)

    Measured: Baseline up to Week 16

  6. Time to Reach Cmax (Tmax)

    Measured: Baseline up to Week 16

  7. Number of Participants Achieving ≥20% Improvement in American College of Rheumatology Score (ACR20)

    Measured: Week 12

  8. Number of Participants Achieving ≥50% Improvement in American College of Rheumatology Score (ACR50)

    Measured: Week 12

  9. Number of Participants Achieving ≥70% Improvement in American College of Rheumatology Score (ACR70)

    Measured: Week 12

  10. Change From Baseline to Week 12 in 28-Joint Disease Activity Score-CRP (DAS28-CRP)

    Measured: Baseline, Week 12

  11. Change From Baseline to Week 12 in 28-Joint Disease Activity Score-ESR (DAS28-ESR)

    Measured: Baseline, Week 12

  12. Change From Baseline to Week 12 in 20- Item Disability Scale and Heath Assessment Questionnaire (HAQ-DI)

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start24 Sep 2026
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion29 Oct 2027 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779616
Sponsor's protocol ID
PTC844-RA-201
Status last verified
Oct 2026
First submitted
18 Aug 2026
Last updated
6 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PTC844 in people with Rheumatoid Arthritis, run by PTC Therapeutics at 26 sites in 4 countries.

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 5 inclusion and 10 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Georgia, South Africa, Mauritius. 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 Patient Advocacy (1-866-562-4620, medinfo@ptcbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07779616.

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 6 Nov 2026.

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