Health TrialsbyHealthPanel

Study of PTC844 in Participants With Active Rheumatoid Arthritis

ConditionRheumatoid Arthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPTC Therapeutics

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PTC844

    Drug

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

  • Placebo

    Drug

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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: PTC844 Low DoseExperimental treatment 1 intervention
Group B: PTC844 High DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline up to Week 16
2

Change From Baseline to Week 2 in Dihydroorotate (DHO)

Time frame
Baseline, Week 2

Secondary outcomes

1

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

Time frame
Baseline, Week 12
2

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

Time frame
Baseline, Week 12
3

Change From Baseline in DHO Over Time

Time frame
Baseline up to Week 16
4

Maximum Observed Plasma Concentration (Cmax) of PTC844

Time frame
Baseline up to Week 16

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PTC Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: