Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Phase 1

• Conditions: Diffuse cutaneous systemic sclerosis (dcSSc); MedDRA version: 20.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-002586-39-IT
• Lead Sponsor: MEDAC GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-06
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Each subject must meet all of the following criteria to be enrolled in this
study (criterion #7 must also be met for inclusion in the open-label
extension phase of the study):
1. Is a male or female =18 years of age.
2. Fulfills the ACR/EULAR 2013 criteria for classification of SSc
3. Has diffuse cutaneous involvement (defined by skin fibrosis in at least
1 of the following sites: upper arms, thorax, abdomen, or thighs)
according to scleroderma classification criteria (LeRoy et al 1988),
confirmed independently by a second investigator who is unaware of the
assessment of the first investigator.
4. Has a baseline mRSS between 10 and 25 units, inclusive.
5. Has had onset of the first non-Raynaud's manifestation of SSc within
36 months of screening.
6. Is willing and able to comply with all aspects of the study; in
particular, has the ability to attend study visits and assessments at least
until the end of the double-blind treatment phase.
7. If a male subject is capable of reproduction or a female subject is of childbearing potential, he/she consents to practice sexual abstinence (Sexual abstinence refers to refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The
reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) or use another highly effective method of contraception (Pearl index < 1), such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion or vasectomy in combination with a second
method of contraception, such as a condom or a cervical cap/diaphragm with spermicide, during the trial and for at least 6 months thereafter.
8. Has provided written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 134
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the
study:
1. Has abnormal hematological values prior to baseline (Visit 2).
2. Has abnormal liver function tests prior to baseline (Visit 2).
3. Has abnormal renal function tests prior to baseline (Visit 2).
4. Has any known renal crisis history.
5. Has cardiac abnormalities at screening (Visit 1).
6. Has any of the following lung criteria at screening (Visit 1):
• Forced vital capacity (FVC) <40% predicted
• Diffusing capacity of the lung for carbon monoxide (DLCO) <30%
predicted.
7. Has a previous diagnosis of severe pulmonary arterial hypertension
(PAH).
8. Has malabsorption requiring parenteral nutrition at screening (Visit
1).
9. Has had treatment with putative disease-modifying agents within 8
weeks of screening.
10. Has had treatment with cyclophosphamide within 26 weeks of
screening (Visit 1).
11. Has had treatment with rituximab within 52 weeks of screening
(Visit 1).
12. Has a known acute or uncontrolled chronic infection (eg, hepatitis B
or C, tuberculosis, or human immunodeficiency virus [HIV]).
13. History of hematopoietic stem cell transplantation or planned
hematopoietic stem cell transplantation within the next 12 months, or
total lymphoid irradiation.
14. Has any concurrent medical condition(s) that, in the opinion of the
investigator, may confound the results of the study.
15. Is pregnant or lactating.

Study & Design

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