Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07746583

A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice

The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Psoriasis 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

Semmelweis University

Budapest, 1088, Hungary

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment
  • Participants who are currently being treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab, or for whom this switch is medically indicated, based on the current and valid national psoriasis (PsO) therapeutic protocol
  • Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab
  • Participants must sign an informed consent form (ICF) allowing for data collection and source data verification in accordance with local requirements

Exclusion criteria

  • Contraindication or hypersensitivity to Guselkumab or any other ingredient in the injection solution
  • Pregnancy or breastfeeding
  • Currently enrolled in an interventional study
  • Currently enrolled in an observational study sponsored or managed by a Janssen company
  • Previous use of guselkumab in any indication in participant history

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab

    Time frame: At Week 20

    Percentage of participants achieving aPASI less than or equal to (<=) 3 at Week 20 following the switch from Ustekinumab to Guselkumab will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Secondary outcomes

  1. Percentage of Participants Achieving aPASI <= 3 at Weeks 4, 12, 36 and 52

    Time frame: At Weeks 4, 12, 36 and 52

    Percentage of participants achieving aPASI <= 3 will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  2. Percentage of Participants Achieving >= 75% Improvement in PASI (PASI 75) at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    Participants with an absolute percentage improvement of at least 75% will be considered having achieved PASI 75 at Weeks 4, 12, 20, 36 and 52. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  3. Percentage of Participants Achieving >= 90% Improvement in PASI (PASI 90) at Weeks 4, 12, 20, 36, and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    Participants with an absolute percentage improvement of at least 90% will be considered having achieved PASI 90 at Weeks 4, 12, 20, 36 and 52. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  4. Percentage of Participants Achieving 100% Improvement in PASI (PASI 100) at Weeks 4, 12, 20, 36, and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    Participants with an absolute percentage improvement of 100% will be considered having achieved PASI 100 at Weeks 4, 12, 20, 36 and 52. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  5. Absolute Changes in PASI Score from Baseline up to Weeks 4, 12, 20, 36 and 52

    Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52

    Absolute changes in PASI scores from baseline to Weeks 4, 12, 20, 36 and 52 will be reported. PASI is a widely used measurement tool used to assess the severity of psoriasis. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  6. Absolute Changes in Body Surface Area (BSA) Score from Baseline up to Weeks 4, 12, 20, 36 and 52

    Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52

    Absolute changes in BSA scores from baseline upto Weeks 4, 12, 20, 36 and 52 will be reported. BSA indicates the percentage of the total body surface area affected by psoriasis. For small-spotted psoriasis lesions, healthy skin between the lesions is not included in the assessment. BSA ranges from 0-100 in which the maximum value is 100.

  7. Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) <=5 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.

  8. Percentage of Participants Achieving Dermatology Life Quality Index Relevant (DLQI-R) <=5 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.

  9. Percentage of Participants Achieving DLQI Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. Scores from all 10 questions are added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.

  10. Percentage of Participants Achieving DLQI-R score of 0 or 1 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.

  11. Absolute Changes in DLQI Scores from Baseline up to Weeks 4, 12, 20, 36 and 52

    Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52

    Absolute changes in DLQI scores from baseline to Week 4, 12, 20, 36 and 52 will be reported. DLQI is a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. The total DLQI score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.

  12. Absolute Changes in DLQI-R Scores from Baseline up to Weeks 4, 12, 20, 36 and 52

    Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52

    Absolute changes in DLQI-R scores from baseline to Week 4, 12, 20, 36 and 52 will be reported. The DLQI-R is calculated by summing the scores of all answered items on the 10-question DLQI questionnaire (each scored 0-3), excluding those marked as "not relevant" (NRR). The total DLQI-R score ranges from 0 (not at all) to 30 (very much). Higher scores indicate more impact on quality of life of participants.

  13. Absolute Change in Static Physician's Global Assessment of Genitalia (sPGA-G) Score Over Time

    Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52

    In participants with anogenital psoriasis at baseline, absolute change in sPGA-G score over time will be reported. The sPGA-G describes the severity of psoriasis using 6 categories. Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis.

  14. Percentage of Participants Achieving sPGA-G Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    In participants with anogenital psoriasis at baseline, the percentage of participants achieving sPGA-G score of 0 or 1 amongst the participants who had a >= 2 sPGA-G score at baseline will be reported. The sPGA-G describes the severity of psoriasis using 6 categories. Accordingly, the score ranges from 0-5, with higher scores indicating more severe psoriasis.

  15. Absolute Change in Physician´s Global Assessment of Hands and/or Feet (hf-PGA) Score Over Time

    Time frame: Baseline up to Weeks 4, 12, 20, 36 and 52

    In participants with palmoplantar psoriasis at baseline, absolute change in hf-PGA score over time will be reported. The hf-PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.

  16. Percentage of Participants Achieving hf-PGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36 and 52

    In participants with palmoplantar psoriasis at baseline, percentage of participants achieving hf-PGA = 0 or 1 amongst the participants who had a >= 2 hf-PGA at baseline will be reported. The hf-PGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.

  17. Absolute Change in Scalp-Specific Investigator Global Assessment (ss-IGA) Score Over Time

    Time frame: Baseline up to Weeks 4, 12, 20, 36, and 52

    In participants with scalp psoriasis at baseline, the absolute change in ss-IGA score over time will be reported. The ss-IGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.

  18. Percentage of Participants Achieving ss-IGA Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36, and 52

    In participants with scalp psoriasis at baseline, the percentage of participants achieving ss-IGA of 0 or 1 amongst the participants who had a >= 2 ss-IGA score at baseline will be reported. The ss-IGA describes the severity of psoriasis using 5 categories. Accordingly, the score ranges from 0-4, with higher scores indicating more severe psoriasis.

  19. Absolute Change in Fingernail Physician's Global Assessment (PGA-F) Score Over Time

    Time frame: Baseline up to Weeks 4, 12, 20, 36, and 52

    In participants with fingernail psoriasis at baseline, absolute change in PGA-F score over time will be reported. The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe). Here, higher scores indicate more severity of psoriasis.

  20. Percentage of Participants Achieving PGA-F Score of 0 or 1 at Weeks 4, 12, 20, 36 and 52

    Time frame: At Weeks 4, 12, 20, 36, and 52

    In participants with fingernail psoriasis at baseline, the percentage of participants achieving PGA-F score of 0 or 1 amongst participants who had a >=2 PGA-F at baseline will be reported. The PGA-F describes the severity of psoriasis using 5 categories and consists of scores ranging from 0 (Clear), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Severe). Here, higher scores indicate more severity of psoriasis.

  21. Demographic Characteristics: Age

    Time frame: At Baseline

    Participant's age at the time of starting guselkumab treatment will be reported.

  22. Demographic Characteristics: Sex

    Time frame: At Baseline

    Sex (male, female) of participants at the time of starting guselkumab treatment will be reported.

  23. Demographic Characteristics: Weight

    Time frame: At Baseline

    Weight of participants at the time of starting guselkumab treatment will be reported.

  24. Demographic Characteristics: Height

    Time frame: At Baseline

    Height of participants at the time of starting guselkumab treatment will be reported.

  25. Clinical Characteristics: Time Since Psoriasis Diagnosis

    Time frame: At Baseline

    Time since psoriasis diagnosis (years), in participants starting guselkumab treatment will be reported.

  26. Clinical Characteristics: Time Since First Symptoms

    Time frame: At Baseline

    Time since first symptoms (years), in participants starting guselkumab treatment will be reported.

  27. Clinical Characteristics: Severity of Psoriasis

    Time frame: At Baseline

    Severity of psoriasis (mild, moderate, severe) in participants starting guselkumab treatment will be reported.

  28. Clinical Characteristics: Affected Areas

    Time frame: At Baseline

    Affected areas (anogenital, nail, scalp, palmoplantar), in participants starting guselkumab treatment will be reported.

  29. Clinical Characteristics: Prior and Baseline Treatments for Moderate to Severe Psoriasis

    Time frame: At Baseline

    Prior and baseline treatments for moderate-to-severe psoriasis, including start and stop dates (in years) in participants starting guselkumab treatment will be reported.

  30. Number of Participants Switching from Ustekinumab or Biosimilars to Guselkumab

    Time frame: At Baseline

    Participants switching treatment and reason for switching treatment from Ustekinumab or biosimilars to Guselkumab will be reported.

  31. Reason for Guselkumab Discontinuation

    Time frame: Up to Week 52

    Number of participants discontinuing guselkumab and reason for guselkumab discontinuation if happens during the study will be reported.

  32. Number of Participants with Specific Psoriatic Comorbidities

    Time frame: At Baseline

    Specific psoriatic comorbidities at baseline will be reported.

  33. Number of Participants with Adverse Events (AE)

    Time frame: Up to Week 52

    An AE is any untoward medical occurrence in a participant administered with a pharmaceutical product. An AE does not necessarily have a causal relationship with the treatment.

Study contacts

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

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Kft.

Industry

Registry information

Official study title

A Non-Interventional, Multi-Centric, Single Country Observational Study to Assess the Safety and Effectiveness of Guselkumab After Ustekinumab (Originator or Biosimilar) in Moderate to Severe Psoriasis Patients in Clinical Routine

Acronym: G-START

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.