A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with Tildrakizumab

• Register: EUCTR
• Last refreshed on: 23 October 2023
• Main ID: EUCTR2018-001060-35-HU
• Date of registration: 21/06/2018
• Prospective Registration: Yes
• Primary sponsor: Sun Pharmaceutical Industries Limited (SPIL)
• Public title: A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with Tildrakizumab
• Scientific title: A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
• Date of first enrolment: 29/08/2018
• Target sample size: 286
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001060-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Hungary, Mexico, Poland, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: Mudgal Kothekar, MD
• Affiliation: Sun Pharma Advanced Research Company Limited

• Name: Mudgal Kothekar, MD
• Affiliation: Sun Pharma Advanced Research Company Limited

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects may be included in the study if they meet all of the following criteria:
1. Subject has provided written informed consent for this long-term extension study.
2. Subjects with PsA who met the inclusion criteria of the parent study and completed the parent study treatment period (e.g., up to Week 48 for the parent Phase 2 study, with return for the EoT assessment at Week 52).
3. PsA subjects who achieved a 20% reduction from Baseline in American College of Rheumatology (ACR)20 response criteria at Week 52, AND the subject has received sufficient clinical benefit, in the opinion of the Investigator, to support continued treatment with tildrakizumab.
Note: This criterion using response criteria at Week 52 of the parent study will apply to all subjects, including those subjects who enter the study from the wash-out phase of their parent study (after Week 52) due to the timing of study site activation of the long-term extension study.
4. No concomitant use of both leflunomide and methotrexate simultaneously.
5. No history of active tuberculosis (TB) or symptoms of TB.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 248
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion criteria:
Subjects should be excluded from the study if they meet any of the following criteria:
1. New onset during the parent study of arthritic conditions other than the subject's original condition.
2. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo-progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 16 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 16 weeks following final administration of IMP.
3. Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 16 weeks after the last dose of IMP.
4. Subject has previously been enrolled in this long-term extension study.
5. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
6. Subject has an active infection or history of infections as follows:
- a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose of the extension study, with the last dose having been received within 7 days of start of the extension study,
- recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this extension study to be detrimental to the subject.
7. Major chronic inflammatory or connective tissue disease other than PsA (e.g., rheumatoid arthritis, systemic lupus erythematosus, Lyme disease, gout, Crohn's disease, etc).
8. Known diagnosis of fibromyalgia, regional pain syndromes or active uveitis/symptomatic inflammatory bowel disease requiring therapy
9. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject.
10. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study
11. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose for this extension study.
12. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
13. Subject has a history of malignancy EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.
14. Subjects with a history of alcohol or drug abuse during the parent study.
15. Significant risk of suicidality at the Baseline assessment of this extension study based on the Investigator's judgment or, if appropriate, as indicated by a response of "yes" since the last visit to question 4 or 5 in the suicidal section, or any response in the behavioral section o

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Psoriatic Arthritis (PsA)
MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: Ilumetri
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tildrakizumab
CAS Number: 1326244-10-3
Current Sponsor code: MK-3222
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): • Adverse events (AEs)/AEs of special interest (AESI)
• Laboratory assessments
• Suicidal ideation and behavior (C-SSRS)
• Vital signs
• ECG
• Physical examination
• ADA to tildrakizumab

Secondary Objective: Not applicable

Main Objective: To assess the long-term safety of tildrakizumab when administered to PsA by evaluation of:
• 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.

Timepoint(s) of evaluation of this end point: • AEs/AESI (Weeks 0, 8, 20, 32, 44, 56, 68, 80, 92, 104, 116, 128, 140, 152, 164, 176, 188, 200 and 208)
• Laboratory assessments (hematology, chemistry and urinalysis, Weeks 0, 20, 56, 104, 152, 200 and 208 only)
• Suicidal ideation and behavior (C-SSRS) (all visits except Week 140, 164 and 188)
• Vital signs (all visits except Week 116, 140, 164 and 188)
• ECG (annually at Weeks 0, 56, 104, 152, 200 and 208 only)
• Physical examination (annually at Weeks 0, 56, 104, 152, 200 and 208 only)
• ADA to tildrakizumab (Weeks 0, 20, 56, 104, 152, 200 and 208 only - Additionally a final ADA sample needs to be collected after 20 weeks from last dose)

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

CLR_18_07

Source(s) of Monetary Support

Sun Pharmaceutical Industries Limited (SPIL)

Ethics review

Status: Approved
Approval date: 14/08/2018
Contact: