Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
An Open-label Extension Study to Assess the Safety and Tolerability of DDY391 in Adult Participants With Active Moderate to Severe Psoriatic Arthritis Who Have Completed Study Treatment in CDDY391A12201
The purpose of this 1-year open-label extension study is to characterize the longer-term safety and tolerability of DDY391 and to assess the durability of clinical response in participants with Psoriatic Arthritis (PsA) who have completed treatment in the CDDY391A12201 core study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a 1-year open label extension (OLE) for participants who completed study treatment in CDDY391A12201 core study. Eligible participants include adults with moderate to severe PsA enrolled in part A or B of the core study who had an inadequate response and/or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs), as well as biologic-naïve participants with an inadequate response and/or intolerance to at least one conventional synthetic DMARD.
Participants must not meet any core study treatment discontinuation criteria at OLE enrollment.
There will be no screening period in this trial. The OLE baseline visit will coincide with Week 12/EOT for Part A and Week 24/EOT for Part B.
Eligible participants will receive open-label DDY391 for up to 52 weeks, followed by a 30-day safety follow-up. The total study duration is 56 weeks.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-post: novartis.email@novartis.com
Studera Kontakt Backup
- Namn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Key Inclusion Criteria:
• Participants must have completed study treatment in CDDY391A12201 and must not meet any treatment discontinuation criteria of the core study at the time of OLE enrollment.
Key Exclusion Criteria:
- Participants taking other prohibited therapies, including but not limited to, high-potency opioids.
- Received live attenuated vaccines 4 weeks prior to baseline or anticipated during the study or within 4 weeks of stopping the study drug.
- Any active viral, bacterial or other infections at the time of extension study entry or history of recurrent clinically significant infection or of recurrent bacterial infections.
- Women of childbearing potential unwilling to use protocol specified method of contraception.
- Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 28 days after stopping study treatment are excluded.
Other protocol-defined inclusion/exclusion criteria may apply.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: DDY391
Participants will receive DDY391 |
DDY391 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Up to 56 Weeks
|
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs. |
Up to 56 Weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDDY391A12201E1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Läkemedels- och apparatinformation, studiedokument
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