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NCT Number: NCT07642544

Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis

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.

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Key information

Conditions

Psoriasis Psoriasis (PsO) Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School

Nanjing, Jiangsu, 210008, China

Location contact

Yue TAO, MD

CONTACT

[email protected]

+86 13851998148

Yue TAO, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years, with a clinical diagnosis of moderate-to-severe plaque psoriasis.
  • Initiated secukinumab treatment at our center between January 2020 and December 2025, and completed the standard 5-week induction period.
  • Achieved PASI 75 response at the end of the induction period.
  • Had a clearly defined maintenance treatment pattern (standard or non-standard), with complete treatment records and regular efficacy assessments.
  • Complete electronic medical record data available for extraction.

Exclusion criteria

  • Failure to complete the induction period, or failure to achieve PASI 75 response by the end of the induction period.
  • Irregular maintenance treatment pattern, or substantial missing data.
  • Use of other targeted biologic agents or small molecule drugs during the maintenance period.
  • Permanent discontinuation of treatment for non-efficacy reasons, such as pregnancy, severe infection, or malignancy.
  • Participation in other interventional clinical trials that may confound efficacy assessment.

Treatment and study plan

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).

Primary outcomes

  1. Time to onset of secondary failure

    Time frame: 36 months

    Secondary failure was defined as a sustained increase in disease activity during maintenance treatment, leading to loss of PASI 50 response.Time to failure was defined as the time from the start of the maintenance period (after Week 5) to the first occurrence meeting the above criteria for secondary failure.PASI 50 is defined as achieving at least a 50% reduction (improvement) from baseline in the Psoriasis Area and Severity Index (PASI) score

Secondary outcomes

  1. Failure-free survival rate

    Time frame: 12, 24, and 36 months

    Failure-free survival rate is defined as the proportion of patients who have not yet experienced a "failure" event at a specific time point.

  2. Proportion of patients receiving different dose escalation strategies

    Time frame: 12, 24, 36 months

    Dose escalation strategies included re-initiation of intensive dosing or shortening of the fixed injection interval (from Q4W to Q2W).

  3. Median time to regain treatment response

    Time frame: 12, 24, 36 months

    To evaluate the median time to regain treatment response (PASI 75) after different dose escalation strategies.PASI 75 is defined as achieving at least a 75% reduction (improvement) from baseline in the Psoriasis Area and Severity Index (PASI) score.

Study contacts

Contact information is provided by the study sponsor or research team.

Yue TAO, MD

CONTACT

[email protected]

+86 13851998148

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis: A Single-Center Real-World Cross-Sectional Retrospective Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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