Marafini, Irene
Stolfi, Carmine
Troncone, Edoardo
Lolli, Elisabetta
Onali, Sara
Paoluzi, Omero Alessandro
Fantini, Massimo C.
Biancone, Livia
Calabrese, Emma
Di Grazia, Antonio
Monteleone, Ivan
Lenti, Marco Vincenzo
Di Sabatino, Antonio
Monteleone, Giovanni
Funding for this research was provided by:
Celgene
NograPharma
Università degli Studi di Roma Tor Vergata
Article History
Accepted: 29 March 2021
First Online: 19 April 2021
Declarations
:
: Open access funding provided by Università degli Studi di Roma Tor Vergata within the CRUI-CARE Agreement. The study was sponsored by Celgene and NograPharma (Mongersen’s owner from April 2020).
: Giovanni Monteleone holds a patent for the use of Smad7 antisense oligonucleotides in CD. Irene Marafini, Carmine Stolfi, Edoardo Troncone, Elisabetta Lolli, Sara Onali, Omero Alessandro Paoluzi, Massimo C. Fantini, Livia Biancone, Emma Calabrese, Antonio Di Grazia, Ivan Monteleone, Marco Vincenzo Lenti, and Antonio Di Sabatino have no conflicts of interest that are directly relevant to the content of this article.
: The study was conducted in accordance with the Declaration of Helsinki, the good clinical practice guidelines established by the International Conference on Harmonisation, and the applicable drug and data protection laws and regulations existing in Italy. Protocols, amendments, and informed consent documentation were reviewed and approved by the institutional review boards and independent ethics committee of each study center before the trial began.
: Written informed consent was obtained from patients before they underwent screening for eligibility.
: Not applicable.
: NCT02685683, EudraCT 2015-001693-18
: Data are available from the corresponding author upon reasonable request.
: Not applicable.
: IMa wrote the paper and collected and analyzed data. CS performed experiments, wrote the paper, and collected and analyzed data. ET, EL, SO, OAP, MCF, LB, EC, and MVL recruited participants and oversaw the study. GM wrote the protocol, oversaw the study, recruited participants, wrote the paper, and analyzed data. ADG and IMo performed experiments. ADS recruited participants and oversaw the study. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.