Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial
Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
You may not be if
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Patients who experienced study treatment-limiting adverse events during the parent trial
Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
Patients with congestive heart disease, as assessed by the investigator
Patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal)
Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)
Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
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