Health TrialsbyHealthPanel

A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis

ConditionModerate to Severe Psoriatic Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this Phase 2a/b study is:

1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA). 2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male participants at least 18 years of age.

Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening.

Moderate to severe PsA at screening and baseline.

Disqualifiers

Presence of inflammatory conditions other than psoriasis or PsA including but not limited to those associated with arthralgia or arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, sarcoidosis) or presence of fibromyalgia or osteoarthritis with articular symptoms.

Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer

Prior use of JAK inhibitors or TYK2 inhibitors (e.g., deucravacitinib). Prior use of apremilast is allowed but must not be taken within 4 weeks of baseline.

Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to baseline.

Trial design

Design model

Sequential

Treatments tested in this trial

  • DDY391

    Drug

    DDY391

  • Placebo

    Drug

    Matching placebo

Treatment groups

220 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part A: DDY391-Schedule 1 Dose AExperimental treatment 1 intervention
Group B: Part A: Placebo Schedule 1Placebo comparator 1 intervention
Group C: Part B: DDY391- Schedule 1 Dose AExperimental treatment 1 intervention
Group D: Part B: DDY391- Schedule 1 Dose BExperimental treatment 1 intervention
Group E: Part B: DDY391- Schedule 1 Dose CExperimental treatment 1 intervention
Group F: Part B: Placebo Schedule 1Experimental treatment 1 intervention
Group G: Part B: DDY391- Schedule 2 Dose CExperimental treatment 1 intervention
Group H: Part B: Placebo Schedule 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response

To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.

Time frame
Week 12
2

Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response

To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.

Time frame
Week 12

Secondary outcomes

1

Part B: Number of participants achieving American College of Rheumatology 50 (ACR50) response

To demonstrate the dose-response relationship of DDY391 compared to placebo in participants.

Time frame
Week 12
2

Part A and Part B: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

Time frame
From first dose through Week 12

Other outcomes

Sponsors and contacts

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

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now