Status:
COMPLETED
Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study
Lead Sponsor:
ISDIN
Collaborating Sponsors:
Digna Biotech S.L.
Conditions:
Skin Fibrosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Transforming growth factor-beta 1 is consistently over expressed in most fibrotic diseases and displays a variety of profibrotic effects in fibroblasts(25, 26). Activation of TGF-beta receptors induce...
Detailed Description
Systemic sclerosis or scleroderma is a multisystemic disorder characterized by the excessive synthesis and deposition of extracellular matrix proteins that result in the fibrosis of skin and visceral ...
Eligibility Criteria
Inclusion
- Previous participation and finalization of treatment period of the ISD002-P144-07 study without clinical relevant safety issues medically evaluated by the investigator.
- For female subjects with childbearing potential: use of a known highly effective method of birth control, defined as those which results in a low failure rate: i.e. less 1% per year, (contraceptive pills, intrauterine contraceptive device, implants, vasectomized partner or sexual abstinence), for at least the extension study period and one month after the end of the extension study.
- For male subjects with partners of childbearing potential:
- use of appropriate contraceptive methods (vasectomy, condoms or sexual abstinence), for at least the extension study period and one month after the end of the extension study.
- Stable therapy for at least one month, except in the case of patients under treatment with putative disease modifying agents (immunosupressants like cyclophosphamide, or azathioprine) that will need at least three months of stable therapy, without the expectation of treatment modifications during the trial period..
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed
Exclusion
- Other skin diseases affecting the treatment area which could have been diagnosed during the ISD002-P144-07 study.
- Woman became pregnant during the ISD002-P144-07 study.
- Any new diagnosis since the ISD002-P144-07 study which includes: systemic sclerosis sine scleroderma, localized escleroderma, eosinophilic fascitis, or eosinophilia myalgia syndrome; any other definable connective tissue disease, such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, or dermatomyositis; clinically significant overlap condition; significant existing internal organ damage as defined in the guidelines for clinical trials in systemic sclerosis; history of skin cancer; other skin diseases affecting the treatment area.
- Substantial history of environmental exposure to tainted rapeseed oil, vinyl chloride, L- tryptophan, bleomycin, trichoroethylene, or silica; PUVA therapy within 1 month of study drug initiation; concurrent interventional therapy that might independently influence outcome of trial, such as D-penicillamine, cyclosporine, methotrexate, interferon-γ or photopheresis; topical corticosteroids treatment affecting the selected area; cosmetics over the treatment area.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00781053
Start Date
July 1 2008
End Date
December 1 2010
Last Update
February 11 2013
Active Locations (17)
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1
Herz- und Rheumazentrum Kerckhoff-Klinik
Bad Hauheim, Bad Hauheim, Germany, 61231
2
Klinikum der Johan Wolfgang Goethe-Universitat
Frankfurt, Frankfurt, Germany, 60590
3
Klinik und Poliklinik für Dermatologie und Vererologie
Cologne, Köln, Germany, 50937
4
Allergie-Centrum-Charité, Abteilung für
Berlin, State of Berlin, Germany, 10117