160. 先天性魚鱗癬 Congenital ichthyosis Clinical trials / Disease details
臨床試験数 : 36 / 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
| 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 | EUCTR2011-000917-38-NL (EUCTR) | 13/09/2013 | 09/07/2013 | CBPR277X2101 | A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome | Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS) MedDRA version: 14.1;Level: LLT;Classification code 10003639;Term: Atopic dermatitis;System Organ Class: 100000004858 MedDRA version: 14.1;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BPR277 INN or Proposed INN: Not available Other descriptive name: BPR277 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 85 | Germany;Netherlands;France;United States | |||
| 2 | EUCTR2011-000917-38-DE (EUCTR) | 14/09/2011 | 18/07/2011 | CBPR277X2101 | A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome | Part 2: Atopic Dermatitis (AD)Part 3: Netherton Syndrome (NS) MedDRA version: 14.1;Level: LLT;Classification code 10003639;Term: Atopic dermatitis;System Organ Class: 100000004858 MedDRA version: 14.1;Level: PT;Classification code 10062909;Term: Netherton's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: BPR277 INN or Proposed INN: not available Other descriptive name: BPR277 Product Code: BPR277 INN or Proposed INN: not available Other descriptive name: BPR277 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 85 | France;United States;Netherlands;Germany | |||
| 3 | NCT01428297 (ClinicalTrials.gov) | May 2011 | 19/8/2011 | A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome | A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome | Healthy Volunteers;Atopic Dermatitis;Netherton Syndrome | Drug: BPR277 ointment (controlled application);Drug: Placebo (Vehicle);Drug: BPR277 ointment;Drug: BPR277 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 12 | Phase 1 | United States;Netherlands;France;Germany |