ALDESLEUKIN ( DrugBank: Aldesleukin )


4 diseases
IDDisease name (Link within this page)Number of trials
49Systemic lupus erythematosus7
65Primary immunodeficiency1
96Crohn disease1
97Ulcerative colitis1

49. Systemic lupus erythematosus


Clinical trials : 993 Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200
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
2EUCTR2016-000488-17-FR
(EUCTR)
16/05/201819/03/2019A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot RecruitingFemale: yes
Male: yes
100Phase 2Portugal;France;Mexico;Spain;Austria;Bulgaria;Italy
3EUCTR2016-000488-17-BG
(EUCTR)
27/03/201713/02/2017A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot RecruitingFemale: yes
Male: yes
100Phase 2Portugal;France;Mexico;Spain;Romania;Austria;Bulgaria;Germany;Italy
4EUCTR2016-000488-17-ES
(EUCTR)
21/11/201618/11/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Portugal;Mexico;Spain;Austria;Bulgaria;Italy
5EUCTR2016-000488-17-PT
(EUCTR)
24/10/201628/07/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
6EUCTR2016-000488-17-AT
(EUCTR)
08/08/201621/07/2016A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2
ILTOO PHARMANULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
7EUCTR2013-001599-40-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. Primary immunodeficiency


Clinical trials : 500 Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
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

96. Crohn disease


Clinical trials : 2,442 Drugs : 1,278 - (DrugBank : 248) / Drug target genes : 142 - Drug target pathways : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04263831
(ClinicalTrials.gov)
March 11, 20217/2/2020Low Dose IL-2 for the Treatment of Crohn's DiseaseLow Dose IL-2 for the Treatment of Crohn's DiseaseCrohn DiseaseDrug: Interleukin-2 (aldesleukin).Boston Children's HospitalNational Institutes of Health (NIH);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years80 YearsAll30Phase 1/Phase 2United States

97. Ulcerative colitis


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02200445
(ClinicalTrials.gov)
February 201522/7/2014Low Dose IL-2 for Ulcerative ColitisA Phase I Study of Low Dose Subcutaneous Interleukin-2 (IL-2) For The Treatment of Ulcerative Colitis.Ulcerative ColitisDrug: Interleukin-2 (aldesleukin).Scott SnapperNULLCompleted18 Years70 YearsAll26Phase 1United States