Psoriatic Arthritis
Conditions
Brief summary
A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
Detailed description
Subjects have rolled over from parent study, i.e., CLR\_16\_23, into the long-term extension study CLR\_18\_07. The study has been open label post 1 year completion.
Interventions
DRUGSUNPG18_07 I (Tildrakizumab 200 mg)
injection
DRUGSUNPG18_07 II (Tildrakizumab 100 mg)
injection
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects will be not be randomized and will enter the long-term extension study with one fixed dose regimen of tildrakizumab, low dose regimen at Week 52 of the parent study. Study was double blind until Databaselock of parent study happened to maintain blinding Subjects continue to assigned treatment from parent study up to week 52 in the Long term extension and there after all subjects began migrating to receive low dose injection Q12 weeks in an open-label fashion for up to an additional 4 years..
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. No concomitant use of both leflunomide and methotrexate, 4. No history of active tuberculosis (TB) or symptoms of TB.
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 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. 7. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus during the parent study. 8. Subjects with a history of alcohol or drug abuse during the parent study. 9. Subject has a need for use of a live vaccine within 10 weeks of final anticipated dose of IMP for the long-term extension study. 10. Concomitant use of prohibited medications or use of commercially available or investigational biologic therapies (other than tildrakizumab) for PsO and/or PsA 11. Subjects who have been placed in an institution on official or judicial orders. 12. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest may arise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | upto week 208 | Please refer to Adverse event section for more information |
Countries
Argentina, Hungary, Mexico, Poland, Russia, Spain, Ukraine, United States
Participant flow
Pre-assignment details
This was a long-term extension (LTE) study in subjects with Psoriatic arthritis who had completed the treatment with tildra in the parent study,CLR\_16\_23(NCT02980692). In LTE, there was no randomization and subjects continued to receive the treatment assigned during the parent study into the LTE upto Wk 52 to maintain blind of the parent study. Post the DBL of CLR 16-23, the blind was no longer needed, all subjects who had entered the LTE study received open label dose of tildra 100 mg q12 wks.
Participants by arm
| Arm | Count |
|---|---|
| Tildrakizumab q4 Weeks, 200 mg The subjects in this group entered the LTE study from the parent study, however, they discontinued from the study and were not switched to the open label tildrakizumab 100 mg q12 weeks dose. | 5 |
| Tildrakizumab 200 mg q12 Weeks The subjects in this group entered the LTE study from the parent study, however, they discontinued from the study and were not switched to the open label tildrakizumab 100 mg q12 weeks dose. | 22 |
| Tildrakizumab 100 mg q12 Weeks These subjects continued to receive same dose of tildrakizumab 100 mg q12 weeks in the LTE study as in the parent study. However, in the LTE study, post DBL of the parent study, the dose was open label. | 49 |
| Tildrakizumab 200 mg q4 Weeks Switched to Tildrakizumab 100 mg q12 Weeks This group represents subjects who switched from tildrakizumab 200 mg q4 weeks dose to open label tildrakizumab 100 mg q12 weeks dose in the LTE study, post DBL of the parent study. | 54 |
| Tildrakizumab 200 mg q12 Weeks Switched to Tildrakizumab 100 mg q12 Weeks This group represents subjects who switched from tildrakizumab 200 mg q12 weeks dose to open label tildrakizumab 100 mg q12 weeks dose in the LTE study, post DBL of the parent study | 151 |
| Total | 281 |
Baseline characteristics
| Characteristic | Tildrakizumab q4 Weeks, 200 mg | Tildrakizumab 200 mg q12 Weeks | Tildrakizumab 100 mg q12 Weeks | Tildrakizumab 200 mg q4 Weeks Switched to Tildrakizumab 100 mg q12 Weeks | Tildrakizumab 200 mg q12 Weeks Switched to Tildrakizumab 100 mg q12 Weeks | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 11.96 | 53.8 years STANDARD_DEVIATION 14.8 | 50.6 years STANDARD_DEVIATION 11.35 | 49.9 years STANDARD_DEVIATION 13.47 | 48.3 years STANDARD_DEVIATION 11.93 | 49.7 years STANDARD_DEVIATION 12.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 6 Participants | 6 Participants | 22 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 19 Participants | 43 Participants | 48 Participants | 129 Participants | 242 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 5 Participants | 21 Participants | 48 Participants | 53 Participants | 147 Participants | 274 Participants |
| Sex: Female, Male Female | 1 Participants | 13 Participants | 28 Participants | 33 Participants | 77 Participants | 152 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 21 Participants | 21 Participants | 74 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 22 | 0 / 49 | 0 / 54 | 1 / 151 |
| other Total, other adverse events | 5 / 5 | 14 / 22 | 36 / 49 | 44 / 54 | 125 / 151 |
| serious Total, serious adverse events | 3 / 5 | 2 / 22 | 7 / 49 | 3 / 54 | 25 / 151 |
Outcome results
Primary
Number of Participants With Adverse Events
Please refer to Adverse event section for more information
Time frame: upto week 208
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tildrakizumab 200 mg q4 Weeks | Number of Participants With Adverse Events | 5 Participants |
| Tildrakizumab 200 mg q12 Weeks | Number of Participants With Adverse Events | 14 Participants |
| Tildrakizumab 100 mg q12 Weeks | Number of Participants With Adverse Events | 36 Participants |
| Tildrakizumab 200 mg q4 Weeks Switched to Tildrakizumab 100 mg q12 Weeks | Number of Participants With Adverse Events | 44 Participants |
| Tildrakizumab 200 mg q12 Weeks Switched to Tildrakizumab 100 mg q12 Weeks | Number of Participants With Adverse Events | 125 Participants |