Kliinilise uuringu otsus nr RKU-4/45

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

16.07.2024 nr RKU-4/45

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Diamyd Medical AB esitas 29.05.2024 Ravimiametile taotluse ravimi

kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) §

991 lõikes 1 sätestatud tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel

anda uuringu sponsorile Diamyd Medical AB loa ravimi kliinilise uuringu läbiviimiseks

vastavalt esitatud uuringuplaanile nr D/P3/21/7 järgmistel tingimustel:

uuringuplaani number: D/P3/21/7 (versioon 6.0 kuupäevaga 19. jaanuar 2024)

uuringu referentsnumber: 22-025

uuringu nimetus: „A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter

Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell

Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the

Genetic HLA DR3-DQ2 Haplotype“

uuringu sponsor: Diamyd Medical AB

uuritavate arv Eestis: 18

vastutavad uurijad ja uuringukeskused:

- Dr Aleksandr Peet, Tartu Ülikooli Kliinikum, L. Puusepa tn 1a, 50406 Tartu, Eesti

- Dr Maire Lubi, Tartu Ülikooli Kliinikum, L. Puusepa tn 1a, 50406 Tartu, Eesti

- Dr Anu Ambos, sihtasutus Põhja-Eesti Regionaalhaigla, J. Sütiste tee 19, 13419

Tallinn, Eesti

- Dr Liina Viitas, Liina Viitas OÜ, Veetorni 2-1, 80018 Pärnu, Eesti

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

Ulf Hannelius

Diamyd Medical AB

P. O. Box 7349

103 90 Stockholm

ROOTSI

2 (2)

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Ott Laius

Peadirektori asetäitja

peadirektori ülesannetes

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

16.07.2024 nr RKU-4/45

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 Diamyd Medical AB on

29.05.2024 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 D/P3/21/7 under the following conditions:

protocol no: D/P3/21/7 (Version 6.0, dated January 19, 2024)

full title of the trial: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter

Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell

Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the

Genetic HLA DR3-DQ2 Haplotype

sponsor of the trial: Diamyd Medical AB

number of subjects in Estonia: 18

principal investigators and study locations:

- Dr Aleksandr Peet, Tartu University Hospital, L. Puusepa tn 1a, 50406 Tartu, Estonia

- Dr Maire Lubi, Tartu University Hospital, L. Puusepa tn 1a, 50406 Tartu, Estonia

- Dr Anu Ambos, North Estonia Medical Centre Foundation, J. Sütiste tee 19, 13419

Tallinn, Estonia

- Dr Liina Viitas, Liina Viitas OÜ, Veetorni 2-1, 80018 Pärnu, Estonia

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

Ulf Hannelius

Diamyd Medical AB

P. O. Box 7349

103 90 Stockholm

SWEDEN

2 (2)

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)

Ott Laius

Deputy Director General

on duties of Director General