Study to test effectiveness and safety of the drug Dupilumab in patients with localized scleroderma

Phase 1

• Conditions: ocalized scleroderma; MedDRA version: 21.1Level: LLTClassification code 10009206Term: Circumscribed sclerodermaSystem Organ Class: 100000004859; MedDRA version: 21.0Level: LLTClassification code 10018124Term: Generalized sclerodermaSystem Organ Class: 100000004859; MedDRA version: 20.0Level: LLTClassification code 10027979Term: MorpheaSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-002036-90-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Subject is a male or female =18 years of age on the day the study informed consent is signed
2. Out-patient status
3. Caucasian, whereby the term comprises people with a light skin type that does not interfere with the evaluation (Fitzpatrick type I-V)
4. Morphea (plaque type) or Generalized localized scleroderma (affecting at least three anatomic sites)
5. At least one lesions with lilac ring (active phase of the disease);
6. Activity of LS within the last 12 month (as defined by progression of size or new developing plaque)
7. For women of childbearing potential: negative pregnancy test at Visit 1
8. For women of childbearing potetnial: Use of effective method of contraceptionfrom 4 weeks prior to enrolment, throughout the study treatment until 12 weeks after the last IMP dose
9. Written informed consent signed

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 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Systemic immunosuppressive therapy or UV therapy in doses relevant for the treatment of Morphea (plaque type) less than 3 months before enrolment.
2. Participation in another trial of IMPs or devices parallel to, or less than 6 months before or previous participation in this trial
3. Pregnancy or breastfeeding mother
4. Diagnosis of other significant chronic inflammatory or autoimmune disorders.
5. Topical immunosuppressive therapy less than 1 month before enrollment
6. Concurrent phototherapy
7. Known infection with helminths (helminthose)
8. Any condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study. E.g. uncontrolled psychiatric illness or history of clinical relevant drug abuse.
9. Known hypersensitivity to any components of the IMP
10. Treatment with a live (attenuated) vaccine within 3 months prior to enrollment
11. Histroy of malignancy (except patients with complteels reated in situ carcinoma of the cervix, completely treated and resolved non-metastatic suamous or basal cell carcinoma or the skin).
12. Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infections or latens untreated tuberculosis unless it is well documented by a specialist that the patient has been adequately treated.
13. Known diagnosis of HIV, HBV or HCV infection
14. Reguklar use (more than 2 visits per week) or a tanning booth/parlor
15. Known diagnosis of asthma including allergic asthma, with pathological lung function test and requirement of daily pharmaceutical treatment at the time of inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified