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

Purpose

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.

Condition

  • Moderate to Severe Psoriatic Arthritis

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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. - History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). - Any active viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: DDY391-Schedule 1 Dose A 		Participants will receive DDY391 Schedule 1 Dose A.
  • Drug: DDY391
    DDY391
Placebo Comparator
Part A: Placebo Schedule 1 		Participants will receive matching placebo Schedule 1.
  • Drug: Placebo
    Matching placebo
Experimental
Part B: DDY391- Schedule 1 Dose A 		Participants will receive DDY391 Schedule 1 Dose A. Based on treatment response, participants will then either continue receiving DDY391 or switch to local standard of care (SOC).
  • Drug: DDY391
    DDY391
Experimental
Part B: DDY391- Schedule 1 Dose B 		Participants will receive DDY391 Schedule 1 Dose B. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.
  • Drug: DDY391
    DDY391
Experimental
Part B: DDY391- Schedule 1 Dose C 		Participants will receive DDY391 Schedule 1 Dose C. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.
  • Drug: DDY391
    DDY391
Experimental
Part B: Placebo Schedule 1 		Participants will receive matching placebo Schedule 1. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
  • Drug: Placebo
    Matching placebo
Experimental
Part B: DDY391- Schedule 2 Dose C 		Participants will receive DDY391 Schedule 2 Dose C. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
  • Drug: DDY391
    DDY391
Experimental
Part B: Placebo Schedule 2 		Participants will receive matching placebo Schedule 2. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
  • Drug: Placebo
    Matching placebo

Recruiting Locations

Rheumatology Associates of South Texas
San Antonio, Texas 78251
Contact:
Veronica Gonzales
VGonzales@biopharmainfo.net

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed Description

This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability and dose-response relationship of DDY391 in participants with active moderate to severe PsA. The study is composed of two sequential parts: - Part A to evaluate efficacy, safety and tolerability of DDY391 compared with placebo. - Part B to determine the dose-response relationship of multiple doses of DDY391 compared with placebo.