Stelara® (Ustekinumab) treatment in Patients with Pyoderma gangrenosum

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2011-002920-41-DE
• Date of registration: 24/08/2011
• Prospective Registration: Yes
• Primary sponsor: University Hospital Tübingen
• Public title: Stelara® (Ustekinumab) treatment in Patients with Pyoderma gangrenosum
• Scientific title: Open-label Trial of Stelara® (Ustekinumab) In Patients with Pyoderma gangrenosum – an open, non-placebo controlled pilot study with 10 patients. - SPG-Trial
• Date of first enrolment: 04/01/2012
• Target sample size: 10
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002920-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Coordinating Investigator
• Affiliation: University Department of Dermatology

• Name: Coordinating Investigator
• Affiliation: University Department of Dermatology

Key inclusion & exclusion criteria

Inclusion criteria:
1. Clinical diagnosis of PG, previously systemically untreated (with the exception of systemic corticosteroids)

2. Measurable disease parameters of PG (color photograph with a ruler).

3. Patients >= 18 years of age

4. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

5. Written, voluntary informed consent. Consent must include investigational use of parts of the obtained tissue material.

6. Screening laboratory test results within the following parameters:
- Haemoglobin =10g/dL
- White blood cells =3.5 x 109/L
- Neutrophils =1.5 x 109/L
- Platelets =100 x 109/L
- Serum creatinine = 1.5 mg/dL (or = 133 mol/L)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels must not exceed three times the upper limit of the normal range for laboratory conducting the test.
7. Eligible according the tuberculosis (TB) criteria

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1. Female patients who are pregnant or breast-feeding.

2. Known diagnosis of human immunodeficiency virus (HIV) infection, Hepatitis B or Hepatitis C.

3. Diagnosed with active or latent TB infection during screening.

4. Any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

5. Currently receiving any other biologic agent.

6. Have previously failed treatment with any therapeutic agent with the exception of systemic corticosteroids.

7. Have previously received any treatment agent directly targeted at reducing IL-12 and/or IL-23.

8. Have received, within 2 weeks prior to the first dose of ustekinumab, a live virus or bacterial vaccination.

9. Have received, or are expected to receive, a BCG vaccination within 12 months prior to screening, during study, or within 12 months after the last administration of study agent.

10. Have a serious infection (eg sepsis, pneumonia or pyelonephritis).

11. Have a transplanted organ (with exception of a corneal transplantat in situ).

12. Have a known history of lymphoproliferative disease.

13. Have any known malignancies or have history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma with tumor thickness =2mm, or cervical carcinoma in situ that has been treated with no evidence of reccurence within 1 year prior to the first administration of study agent).

14. Have a known hypersenstitivity to ustekinumab or any of its excipients.

15. Is a prisoner

16. Participation in another clinical trial whilst this study or within the last 30 days preliminary to this study

17. Have any condition that, in the opinion of the investigator, would compromise the well being of the patient or the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Patients with a clinical diagnosis of Pyoderma gangrenosum
MedDRA version: 14.1 Level: LLT Classification code 10037634 Term: Pyoderma gangenosum System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Intervention(s)

Trade Name: Stelara
Product Name: Ustekinumab
Pharmaceutical Form: Solution for injection
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 45-90

Primary Outcome(s)

Secondary Objective: - To assess changes in PG-inflammation Score, Wound Score and Visual Analogue Pain Scale (VAPS).

- To assess the safety and tolerability of Stelara in patients with PG.

- To assess, where feasible, the functional significance of the expression pattern of inflammatory cytokines, particularly IL-23, in PG tissue as obtained by biopsies before the beginning of and after the treatment with Stelara and by blood samples before, during and after treatment with Stelara
• Evaluation of the expression of these cytokines and/or associated inflammatory molecules
• Assessment of the type of Th immune response before, during and after treatment with Stelara
• Correlation of the results from the analyses mentioned above with the clinical outcome of PG patients.

- To asses changes in quality of life, including the dermatology Life Quality Index (DLQI)

Timepoint(s) of evaluation of this end point: week 28

Primary end point(s): Change of the PG-inflammation SCORE from baseline to week 28

Main Objective: To confirm the efficacy and immunological response of Stelara® therapy in patients with PG

Secondary Outcome(s)

Secondary end point(s): - Change of PG-adapted RECIST criteria
- Wound Score and Visual Analogue Pain Scale from baseline to week 28
- The incidence and grading of adverse events and abnormal laboratory cytometry
- Cytokine expression of monocytes and T-cells
- Cytokine and immunohistological studies to analyze the cytokine profile in the punch biopsies of PG patients under Stelara® therapy
- Analysis of the phenotype and intracellular cytokine profile of Mononuclear cells and lymphocytes.

Timepoint(s) of evaluation of this end point: week 16 and 28

Secondary ID(s)

StelaraPG01

Source(s) of Monetary Support

Janssen-Cilag GmbH

Ethics review

Status: Approved
Approval date: 27/12/2011
Contact: