A Open-label Study to Evaluate the Efficacy, Safety, Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Laborértékek

• "1. Anticipated use of another investigational agent for any condition during the course of the trial. 2. New diagnosis of malignant condition after enrolling in Trial HZNPHZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 3. Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. Women are considered of childbearing potential if they are not postmenopausal and not surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy or hysterectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Fertile male subjects must use a condom throughout the trial and for 4 weeks after the last dose of trial drug. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. 4. Pregnant or lactating women. 5. Any new development with the subject's disease or condition or any significant laboratory test abnormality during the course of Trial HZNPHZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk. 6. Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial. "

• Written informed consent. 2. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; subjects prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments. 3. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. "