Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study ID
- NCT07642544
- Status
- Not Yet Recruiting
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Conditions
- Psoriasis
- Psoriasis (PsO)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Standard Maintenance — DRUG5-week standard induction period (Weeks 0, 1, 2, 3, 4) followed by 300 mg maintenance treatment with ≥90% of recorded injection intervals falling within every 4 weeks ± 7 days (21-35 days).
- Non-standard Maintenance — DRUG5-week standard induction period (Weeks 0, 1, 2, 3, 4) followed by at least 3 consecutive documented 300 mg maintenance injections with intervals all longer than 5 weeks (\>35 days); or followed by at least 3 consecutive documented 150 mg maintenance injections with intervals falling within every 4 weeks ± 7 days (21-35 days).
Study Details
To evaluate the long-term efficacy of two maintenance treatment patterns of secukinumab-the standard maintenance group and the non-standard maintenance group-by assessing the median time to onset and incidence of secondary failure, as well as the time to regain response after dose escalation of secukinumab (including re-initiation of intensive dosing or shortening of the injection interval) in patients who experienced secondary failure.
Key Dates
- First listed
- Jun 11, 2026
- Start date
- Jun 1, 2026
- Status verified
- May 2026
- Primary completion
- Dec 1, 2026
- Completion
- Mar 1, 2027
Study Design
- Enrollment
- 120 participants (estimated)
Arms
- Arm: standard maintenance cohortPatients who, after completing the 5-week standard induction period (Weeks 0, 1, 2, 3, 4), received 300 mg maintenance treatment with ≥90% of recorded injection intervals falling within every 4 weeks ± 7 days (21-35 days).
- Arm: non-standard maintenance cohortPatients who, after completing the standard induction period, during the maintenance treatment phase, had either: at least 3 consecutive documented 300 mg maintenance injections with intervals all longer than 5 weeks (\>35 days); or at least 3 consecutive documented 150 mg maintenance injections with intervals falling within every 4 weeks ± 7 days (21-35 days).
Primary Outcome Measure
Time to onset of secondary failure [ Time Frame: 36 months ]
Central Contacts
- Yue TAO, MD+86 13851998148
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