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Not yet recruitingNCT07642544Updated Jun 11, 2026

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

An observational study in Psoriasis and Psoriasis (PsO), sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Psoriasis
  • Psoriasis (PsO)

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Keywords

  • psoriasis
  • secukinumab
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In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 396 observational studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with moderate-to-severe plaque psoriasis

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

    Drug: Standard Maintenance

  • 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).

    Drug: Non-standard Maintenance

Interventions

  • DrugStandard Maintenance

    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).

  • DrugNon-standard Maintenance

    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).

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What researchers measure

Primary outcomes

  1. Time to onset of secondary failure

    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

    Time frame: 36 months

Secondary outcomes

  1. Failure-free survival rate

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

    Time frame: 12, 24, and 36 months

  2. Proportion of patients receiving different dose escalation strategies

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

    Time frame: 12, 24, 36 months

  3. Median time to regain treatment response

    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.

    Time frame: 12, 24, 36 months

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Study locations

1 site
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School
    Nanjing, Jiangsu 210008, China
    • Yue TAO, MD · Contact · taoyue@126.com · +86 13851998148
    • Yue TAO, MD · Principal investigator
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References and documents

Publications

  • Gambardella A, Licata G, Sohrt A. Dose Adjustment of Biologic Treatments for Moderate-to-Severe Plaque Psoriasis in the Real World: A Systematic Review. Dermatol Ther (Heidelb). 2021 Aug;11(4):1141-1156. doi: 10.1007/s13555-021-00559-z. Epub 2021 Jun 3. PubMed 34081304 ↗
  • Menter A, Papp KA, Gooderham M, Pariser DM, Augustin M, Kerdel FA, Fakharzadeh S, Goyal K, Calabro S, Langholff W, Chavers S, Naessens D, Sermon J, Krueger GG. Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1148-58. doi: 10.1111/jdv.13611. Epub 2016 Mar 30. PubMed 27027388 ↗
  • Nast A, Altenburg A, Augustin M, Boehncke WH, Harle P, Klaus J, Koza J, Mrowietz U, Ockenfels HM, Philipp S, Reich K, Rosenbach T, Schlaeger M, Schmid-Ott G, Sebastian M, von Kiedrowski R, Weberschock T, Dressler C. German S3-Guideline on the treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - Part 1: Treatment goals and treatment recommendations. J Dtsch Dermatol Ges. 2021 Jun;19(6):934-150. doi: 10.1111/ddg.14508. No abstract available. PubMed 34139083 ↗
  • Blauvelt A, Reich K, Tsai TF, Tyring S, Vanaclocha F, Kingo K, Ziv M, Pinter A, Vender R, Hugot S, You R, Milutinovic M, Thaci D. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017 Jan;76(1):60-69.e9. doi: 10.1016/j.jaad.2016.08.008. Epub 2016 Sep 20. PubMed 27663079 ↗
  • Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9. PubMed 25007392 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07642544
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
taoyue (MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Jun 11, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Jun 11, 2026

Study contacts

Yue TAO, MD
Contact
taoyue18@126.com
+86 13851998148

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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