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Clinical Trial Results:
A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab

Summary
EudraCT number	2018-001060-35
Trial protocol	HU ES PL
Global end of trial date	18 Sep 2023

Results information
Results version number	v1(current)
This version publication date	03 Oct 2024
First version publication date	03 Oct 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CLR_18_07

ISRCTN number

US NCT number

NCT03552276

WHO universal trial number (UTN)

Sponsor organisation name

Sun Pharmaceutical Industries Limited (SPIL)

Sponsor organisation address

17/B, Mahal Industries Limited, Mahakali Caves Road, Andheri(East), Mumbai, Mumbai, India,

Public contact

Shantanu Bhushankumar Mehta, General Manager, Sun Pharmaceutical Industries Limited (SPIL) , Clinical.Trial@sunpharma.com

Scientific contact

Shantanu Bhushankumar Mehta, General Manager, Sun Pharmaceutical Industries Limited (SPIL) , Clinical.Trial@sunpharma.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

18 Sep 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

18 Sep 2023

Global end of trial reached?

Yes

Global end of trial date

18 Sep 2023

Was the trial ended prematurely?

Main objective of the trial

To assess the long-term safety of tildrakizumab when administered to PsA by evaluation of subjects: • Incidence and intensity of all AEs, • Changes in vital signs, laboratory assessments, electrocardiograms (ECGs), and Columbia-Suicide Severity Rating Scale (C-SSRS), • Immunogenicity of multiple-dose administration of tildrakizumab in these subjects.

Protection of trial subjects

The following measures were in place during the execution of the study to ensure safety and protection of trial subjects: • All subjects underwent Screening procedures at the start of their parent study aimed at reducing the likelihood and impact of any risks. • In addition, regular safety monitoring during the treatment period of the parent study and the long-term extension study for all subjects ensured that any unanticipated effects of study participation were identified promptly and managed appropriately. • The design allowed withdrawal of subjects from tildrakizumab at the end of the parent study (in accordance with the current parent protocol wash-out phase) and at any time thereafter during the extension study if, in the opinion of the Investigator, the subject was no longer obtaining sufficient clinical benefit, thus enabling subjects to receive other treatment in accordance with local clinical practice. • Clinical adjudication committee was established to monitor cardiovascular events

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Jul 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country