Using gen and protein expression to gain insights in the development of psoriasiform skin lesions under anti-TNF therapy, and predicting response to ustekinumab.

STRAUSS: responSe To ustekinumab foR Anti-tnf IndUced pSoriasiform Skin lesions - STRAUSS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003189-15-BE

Enrollment

Registered

2018-09-05

Start date

2018-10-05

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-TNF induced psoriasiform skin lesions in patients with inflammatory bowel diseases

Interventions

Trade Name: Stelara Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Other descriptive name: USTEKINUMAB Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All IBD patients aged 18 to 80-years-old who are currently being treated with anti-TNF therapy and who have developed psoriasiform skin lesions (including psoriasiform eczema, psoriasis guttata, psoriasis inversa and pustulosis) and which are refractory to at least 12 weeks of topical therapy. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - IBD patients not treated with anti-TNF therapy - IBD patients with paradoxical skin lesions due to anti-TNF who are not refractory to topical therapy - Patients who previously received anti-IL12/23 or anti-IL23 therapy or vedolizumab. - Pregnant IBD patients

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this prospective, observational study is to indentify transcriptomic and proteomic signatures, which can predict good response to ustekinumab in anti-TNF treated patients with psoriasiform skin lesions;Secondary Objective: The secondary objective will include elucidating the changes that occur in the psoriasiform skin lesions when the patient is switched from anti-TNF therapy to ustekinumab or vedolizumab. This is to better understand the mechanisms that contribute to the development of these psoriasiform skin lesions.;Primary end point(s): The primary end point is to identify gene and protein expression profiles that predict good response of anti-TNF induced psoriasiform skin lesions to ustekinumab;Timepoint(s) of evaluation of this end point: within a year after termination of the study	—

Measure

Time frame

Main Objective: The primary objective of this prospective, observational study is to indentify transcriptomic and proteomic signatures, which can predict good response to ustekinumab in anti-TNF treated patients with psoriasiform skin lesions;Secondary Objective: The secondary objective will include elucidating the changes that occur in the psoriasiform skin lesions when the patient is switched from anti-TNF therapy to ustekinumab or vedolizumab. This is to better understand the mechanisms that contribute to the development of these psoriasiform skin lesions.;Primary end point(s): The primary end point is to identify gene and protein expression profiles that predict good response of anti-TNF induced psoriasiform skin lesions to ustekinumab;Timepoint(s) of evaluation of this end point: within a year after termination of the study

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary end point is to identify mechanistic changes that occur in the skin when the study participants are switched from anti-TNF therapy to either ustekinumab or vedolizumab (control group).;Timepoint(s) of evaluation of this end point: within the year after termination of the study	—

Countries

Belgium

Contacts

Public ContactClinical Trial Center UZ Leuven

University Hospitals Leuven

ctc@uzleuven.be+321634 19 98

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026