AP1189 ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 7 |
| 222 | 一次性ネフローゼ症候群 | 3 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05604885 (ClinicalTrials.gov) | November 30, 2022 | 31/10/2022 | A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE) | Rheumatoid Arthritis | Drug: AP1189, 60 mg;Drug: AP1189, 80 mg;Drug: AP1189, 100 mg;Drug: Placebo | SynAct Pharma Aps | NBCD A/S | Recruiting | 18 Years | 85 Years | All | 420 | Phase 2 | Moldova, Republic of |
| 2 | NCT05516979 (ClinicalTrials.gov) | September 26, 2022 | 24/8/2022 | A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment | A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment | Rheumatoid Arthritis | Drug: 100 mg AP1189;Drug: Placebo | SynAct Pharma Aps | NBCD A/S | Recruiting | 18 Years | 85 Years | All | 120 | Phase 2 | Moldova, Republic of |
| 3 | EUCTR2019-001185-15-BG (EUCTR) | 29/05/2020 | 15/05/2020 | A 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 effect | 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 4 | EUCTR2019-001185-15-NO (EUCTR) | 19/02/2020 | 07/11/2019 | A 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 effect | 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 5 | EUCTR2019-001185-15-SE (EUCTR) | 06/11/2019 | 01/07/2019 | A 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 effect | 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden | ||
| 6 | NCT04004429 (ClinicalTrials.gov) | August 26, 2019 | 26/6/2019 | A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease | A 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 Disease | Rheumatoid Arthritis | Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo | SynAct Pharma Aps | NULL | Completed | 18 Years | 85 Years | All | 105 | Phase 2 | Denmark;Norway |
| 7 | EUCTR2019-001185-15-DK (EUCTR) | 06/06/2019 | 12/04/2019 | 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 | 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 ApS | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden |
222. 一次性ネフローゼ症候群
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-000971-18-NO (EUCTR) | 28/06/2021 | 23/02/2021 | A 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 effect | An 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | Denmark;Norway | ||
| 2 | NCT04456816 (ClinicalTrials.gov) | August 31, 2020 | 24/6/2020 | A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria | An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria | Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy;Severe Proteinuria Due to Idiopathic Membranous Nephropathy | Drug: 100 mg AP1189;Drug: Placebo | SynAct Pharma Aps | NULL | Recruiting | 18 Years | 85 Years | All | 23 | Phase 2 | Denmark |
| 3 | EUCTR2020-000971-18-DK (EUCTR) | 28/05/2020 | 04/04/2020 | A 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 effect | An 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 ApS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | Denmark |