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

NCT07642544 | Not Yet Recruiting

• 1 other identifier: SEMLOP
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Psoriasis (PsO)

Keywords

psoriasis; secukinumab

Outcome Measures

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

  36 months

Secondary Outcomes (3)

• Failure-free survival rate

  12, 24, and 36 months

• Proportion of patients receiving different dose escalation strategies

  12, 24, 36 months

• Median time to regain treatment response

  12, 24, 36 months

Study Arms (2)

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

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).

standard maintenance cohort

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).

non-standard maintenance cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with moderate-to-severe plaque psoriasis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

Related Publications (5)

• 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.

  PMID: 34081304 BACKGROUND

• 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.

  PMID: 27027388 BACKGROUND

• 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.

  PMID: 34139083 BACKGROUND

• 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.

  PMID: 27663079 BACKGROUND

• 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.

  PMID: 25007392 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yue TAO, MD

CONTACT

+86 13851998148; taoyue18@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)