Kliinilise uuringu otsus nr RKU-4/54

Nooruse 1 / 50411 Tartu / 737 4140 / info@ravimiamet.ee / www.ravimiamet.ee / Registrikood 70003477

24.07.2024 nr RKU-4/54

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor AbbVie Deutschland

GmbH & Co. KG on 02.04.2024 to conduct a clinical trial under the conditions stipulated in

Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act

(MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no M23-703 under the following conditions:

protocol no: M23-703 (Version 2.1.1, dated July 12, 2024)

full title of the trial: A Multicenter, Randomized Study to Evaluate the Safety and Efficacy

of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to

Severely Active Ulcerative Colitis

sponsor of the trial: AbbVie Deutschland GmbH & Co. KG

number of subjects in Estonia: 4

starting date: August 2024

principal investigators and study locations:

- Dr Leana Sits, sihtasutus Pärnu Haigla, Ristiku tn 1, 80010 Pärnu, Estonia

- Dr Külliki Suurmaa, Lääne-Tallinna Keskhaigla AS, Paldiski mnt 68, 10617 Tallinn,

Estonia

- Dr Julia Borissova, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419

Tallinn, Estonia

- Dr Karin Kull, Tartu University Hospital, L. Puusepa tn 1a, 50406 Tartu, Estonia

Rita Kuzminiene

AbbVie OÜ

Rävala 4

10145 Tallinn

ESTONIA

2 (2)

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

(digitally signed)

Katrin Kiisk

Director General