AP1189 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
46Malignant rheumatoid arthritis5
222Primary nephrotic syndrome3

46. Malignant rheumatoid arthritis


Clinical trials : 4,325 Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001185-15-BG
(EUCTR)
29/05/202015/05/2020A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effectA double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
2EUCTR2019-001185-15-NO
(EUCTR)
19/02/202007/11/2019A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effectA double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
3EUCTR2019-001185-15-SE
(EUCTR)
06/11/201901/07/2019A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effectA double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
4NCT04004429
(ClinicalTrials.gov)
August 26, 201926/6/2019A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint DiseaseA Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint DiseaseRheumatoid ArthritisDrug: 50 mg AP1189;Drug: AP1189;Drug: PlaceboSynAct Pharma ApsNULLCompleted18 Years85 YearsAll105Phase 2Denmark;Norway
5EUCTR2019-001185-15-DK
(EUCTR)
06/06/201912/04/2019A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002 rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLNot RecruitingFemale: yes
Male: yes
135Phase 2Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden

222. Primary nephrotic syndrome


Clinical trials : 285 Drugs : 285 - (DrugBank : 108) / Drug target genes : 62 - Drug target pathways : 191
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000971-18-NO
(EUCTR)
28/06/202123/02/2021A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effectAn exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003 Idiopathic membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 2Denmark;Norway
2NCT04456816
(ClinicalTrials.gov)
August 31, 202024/6/2020A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMNAn Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 4 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous NephropathyIdiopathic Membranous NephropathyDrug: 100 mg AP1189;Drug: PlaceboSynAct Pharma ApsNULLRecruiting18 Years85 YearsAll23Phase 2Denmark
3EUCTR2020-000971-18-DK
(EUCTR)
28/05/202004/04/2020A double-blind study for patients with idiopathic membranous nephropathy in treatment with ACE inhibor or angiotensin II receptor blockers. The trial will take place in hospitals in Europe. To better assess the mechanism of action of AP1189, the compound is compared to an inactive substance (placebo).The purpose of the trial is to investigate the safety of the new drug, its tolerability, uptake, metabolism, distribution, and excretion in the body (pharmacokinetics) and its effectAn exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003 Idiopathic membranous nephropathy
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: PT;Classification code 10029164;Term: Nephrotic syndrome;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: AP1189
INN or Proposed INN: Not applicable
SynAct Pharma ApSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 2Denmark