49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| 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 | EUCTR2017-004060-35-HU (EUCTR) | 12/03/2018 | 10/01/2018 | An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLE | An open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Systemic 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: IPP-201101 Product Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Mauritius | ||
| 2 | NCT03427151 (ClinicalTrials.gov) | February 27, 2018 | 8/12/2017 | Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101 | ImmuPharma | NULL | Completed | 18 Years | N/A | All | 62 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland |
| 3 | EUCTR2015-003341-25-GB (EUCTR) | 17/10/2016 | 22/09/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic 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 Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Germany;United Kingdom | ||
| 4 | EUCTR2015-003341-25-DE (EUCTR) | 29/07/2016 | 17/03/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic 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 Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Germany;United Kingdom | ||
| 5 | EUCTR2015-003341-25-IT (EUCTR) | 06/07/2016 | 19/01/2021 | Uno studio per valutare l'efficacia e la sicurezza del farmaco in studio, quando ai pazienti ¿ dato un dosaggio di 200 mcg di IPP-201101 pi¿ standard di cura, in pazienti con lupus eritematoso sistemico. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic 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 Code: IPP-201101 | IMMUPHARMA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;Hungary;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2015-003341-25-HU (EUCTR) | 02/05/2016 | 07/03/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 18.1;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 Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Hungary;Germany | ||
| 7 | EUCTR2015-003341-25-FR (EUCTR) | 24/02/2016 | 20/04/2016 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic 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 Code: IPP-201101 INN or Proposed INN: IPP-201101 | ImmuPharma SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Hungary;Germany | ||
| 8 | NCT02504645 (ClinicalTrials.gov) | March 2015 | 17/7/2015 | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101;Drug: Placebo;Other: Standard of Care | ImmuPharma | NULL | Completed | 18 Years | 70 Years | All | 202 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy |
| 9 | EUCTR2010-019293-32-BE (EUCTR) | 10/05/2011 | 19/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | ||
| 10 | EUCTR2010-019293-32-DE (EUCTR) | 10/02/2011 | 16/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | |||
| 11 | EUCTR2010-018383-16-BE (EUCTR) | 10/11/2010 | 19/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | ||
| 12 | EUCTR2010-019293-32-PT (EUCTR) | 01/10/2010 | 26/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 13 | EUCTR2010-018383-16-PT (EUCTR) | 01/10/2010 | 23/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 14 | EUCTR2010-019293-32-ES (EUCTR) | 28/09/2010 | 21/07/2010 | Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Pacientes con lupus eritematoso sístemico (LES). Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Portugal;Czech Republic;Hungary;Belgium;Spain;Germany | ||
| 15 | EUCTR2010-018383-16-DE (EUCTR) | 17/09/2010 | 16/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | |||
| 16 | EUCTR2010-019293-32-CZ (EUCTR) | 19/08/2010 | 22/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Poland;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Ukraine;Germany | |||
| 17 | EUCTR2010-019293-32-HU (EUCTR) | 16/08/2010 | 21/07/2010 | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Portugal;Hungary;Czech Republic;Spain | ||||
| 18 | EUCTR2010-018383-16-HU (EUCTR) | 16/08/2010 | 20/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland | |||
| 19 | EUCTR2010-018383-16-CZ (EUCTR) | 13/08/2010 | 22/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 20 | EUCTR2010-018383-16-ES (EUCTR) | 10/08/2010 | 20/07/2010 | Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;Portugal;Czech Republic;Hungary;Belgium;Spain;Germany | ||
| 21 | EUCTR2010-018383-16-FR (EUCTR) | 05/08/2010 | 29/07/2010 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany | ||
| 22 | EUCTR2007-004892-21-BG (EUCTR) | 16/04/2008 | 15/04/2008 | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes) | Product Code: IPP-201101 INN or Proposed INN: IPP - 201101 Other descriptive name: P 140 | IMMUPHARMA SA | NULL | Not Recruiting | Female: yes Male: yes | 296 | Phase 2 | Bulgaria;Spain |