What are the guidelines or recommendations from regulatory agencies regarding open-label trials?

Objective. Irritable bowel syndrome (IBS) is commonly comorbid with generalized anxiety disorder (GAD). We evaluated whether duloxetine would lead to ... May 29, 2024 ... Infusion of mbIL-7-TIL has acceptable safety and potent efficacy in recurrent OC patients who have limited treatment options. (143) - Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement ... Jan 4, 2024 ... Participants were randomly assigned to treatment with the glucagon-like peptide 1 receptor agonist semaglutide or the sodium–glucose cotransporter 2 inhibitor ... Oct 30, 2019 ... The study included children aged between 8 and 17 years, with moderate to severe psoriasis, given tofacitinib 5 mg orally twice daily for at least 36 weeks. An open-label, proof-of-concept phase II clinical trial was conducted in 10 PAP patients. The intervention consisted of two intravenous infusions of rituximab ( ... A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) compared to ... Abstract. Many oncology clinical trials are randomized open-label trials. In order to minimize operational bias while not hindering critical activities in ... Official Title. A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered ... Oct 20, 2023 ... Dermavant presents positive results from Phase 4 open-label trial of VTAMA (tapinarof) cream, 1% for the treatment of intertriginous plaque psoriasis in adults.