7 results
The primary objective of this study is to investigate local and systemic effects of BAY 1007626 on:- Number of bleeding and spotting days,- Endometrial histology,- Ovulation (as surrogate for systemic effects).The secondary objective of this study…
To evaluate the safety and tolerability of long term treatment with ontamalimab in subjects with moderate to severe UC or CD.
The aim is to determine on the basis of the results of this study whether there is measurable effect on the ability to drive after long term use of ICADTS class III drugs. To achieve this goal drugs will be tested out of the groups most commonly…
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…
Primary: To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:* To evaluate the…