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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard Maintenance — DRUG
    5-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 — DRUG
    5-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 cohort
    Patients 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 cohort
    Patients 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

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