ClinicalTrials.gov
ClinicalTrials.gov Menu

Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions (STRAUSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03629379
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
Using transcriptomics and proteomics to gain insights in the development of psoriasiform skin lesions under anti-tumor necrosis factor (TNF) therapy, and predicting response to ustekinumab.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Psoriasis Drug: Ustekinumab Drug: Vedolizumab Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, interventional study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ustekinumab arm
First 10 patients who are switched from anti-TNF to ustekinumab because of psoriasiform skin lesions refractory to 12 weeks of topical therapy.
Drug: Ustekinumab
Patients will receive standard dosing of ustekinumab with a single intravenous infusion of about 6mg/kg ustekinumab at week 0, followed by ustekinumab 90mg subcutaneously every 8 weeks.
Other Names:
  • Clinical disease activity of inflammatory bowel disease
  • Digital pictures of skin lesions
  • Scoring of (severity) of anti-TNF induced skin lesions
  • Skin biopsies
  • Blood sampling
  • Stool sampling

Active Comparator: vedolizumab arm
First 10 patients who are switched from anti-TNF to vedolizumab because of psoriasiform skin lesions refractory to 12 weeks of topical therapy.
Drug: Vedolizumab
Patients will receive standard dosing of vedolizumab 300mg at weeks 0, 2, 6, and 14. Patients with Crohn's disease could receive an extra infusion at week 10.
Other Names:
  • Clinical disease activity of inflammatory bowel disease
  • Digital pictures of skin lesions
  • Scoring of (severity) of anti-TNF induced skin lesions
  • Skin biopsies
  • Blood sampling
  • Stool sampling




Primary Outcome Measures :
  1. Transcriptomic features [ Time Frame: 3 years ]
    Transcriptomic profile will be established by analysis of the expression of the mRNAs by using Next Generation Sequencing.


Secondary Outcome Measures :
  1. Proteomic features [ Time Frame: 3 years ]
    Proteomic profile will be established by using a proximity extension assay from OLINK

  2. Mechanistic changes in psoriasiform skin lesions [ Time Frame: 3 years ]
    Physiological changes that occur with respect to cell types and cytokines will be investigated using immunohistochemistry and cell sorting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with CD or UC, who develop psoriasiform skin lesions (including psoriasiform eczema, psoriasis guttata, psoriasis inversa and pustulosis) under therapy with anti-TNF and refractory to at least 12 weeks of topical therapy.
  • Written informed consent must be obtained and documented.

Exclusion Criteria:

  • IBD patients not treated with anti-TNF therapy
  • IBD patients with skin lesions under anti-TNF not refractory to topical therapy
  • Patients who previously received anti-interleukin 12/23 (IL12/23) or anti-interleukin 23 therapy
  • Patients with history of psoriasis prior to initiation of anti-TNF therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629379


Contacts
Contact: Marc Ferrante, MD 003216342845 marc.ferrante@uzleuven.be
Contact: Annick Moens, MD 003216340998 annick.moens@kuleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

Publications of Results:

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03629379     History of Changes
Other Study ID Numbers: S61472
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data (IPD) sharing

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Psoriasis
Inflammatory Bowel Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Vedolizumab
Dermatologic Agents
Gastrointestinal Agents