Proleukin ( DrugBank: - )

3 diseases
告示番号疾患名（ページ内リンク）臨床試験数
2筋萎縮性側索硬化症1
49全身性エリテマトーデス2
65原発性免疫不全症候群1

2. 筋萎縮性側索硬化症

臨床試験数 : 624 /  薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-005347-14-GB
(EUCTR)		25/08/201609/05/2016Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patientsEfficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients:A randomized, double-blind, placebo- controlled, phase-II Proof of Concept/ Proof of Mechanism Clinical Trial - MIROCALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Trade Name: Proleukin 18 MUI
Product Name: proleukin		CHU DE NIMESNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		216Phase 2United Kingdom

49. 全身性エリテマトーデス

臨床試験数 : 946 /  薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03312335
(ClinicalTrials.gov)		August 8, 201829/9/2017Low-dose Interleukin-2 for Treatment of Systemic Lupus ErythematosusOpen-label, Monocentric, Phase II, Investigator-initiated Clinical Trial on Unbiased Characterization of Immunological Parameters in Interleukin-2-treated Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Low-dose Aldesleukin (Proleukin®)Onur Boyman, MDNULLCompleted18 YearsN/AAll16Phase 2Switzerland
2EUCTR2013-001599-40-DE
(EUCTR)		03/01/201414/11/2013Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus.Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN).A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMMUN Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies.
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Classification code 10067657;Term: Systemic lupus erythematosus disease activity index increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: Proleukin
Product Name: Proleukin
INN or Proposed INN: Aldesleukin
Other descriptive name: ALDESLEUKIN		Charité - Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes		12Phase 1;Phase 2Germany

65. 原発性免疫不全症候群

臨床試験数 : 482 /  薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-003369-27-DE
(EUCTR)		01/07/201618/05/2016A Phase I-IIa trial on low-dose IL-2 (Aldesleukin) treatment for immunological dysregulation in common variable immunodeficiency (CVID)A Phase I-IIa trial on low-dose IL-2 (Aldesleukin) treatment for immunological dysregulation in common variable immunodeficiency (CVID) - REGAIN: REGulatory T cells and Aldesleukin for Immunodeficiency- associated eNteropathy autoimmune enteropathy (AIE) in common variable immunodeficiency (CVID).
MedDRA version: 19.0;Level: PT;Classification code 10021449;Term: Immunodeficiency common variable;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 19.0;Level: LLT;Classification code 10017922;Term: Gastroenteropathy NOS;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Trade Name: PROLEUKIN® S
Product Name: Aldesleukin
INN or Proposed INN: Aldesleukin
Other descriptive name: ALDESLEUKIN		Universitätsklinikum FreiburgNULLNot RecruitingFemale: yes
Male: yes		6Phase 2Germany