The Safety and Efficacy of a Novel HSP90 Inhibitor (CUDC-305) in the Treatment of Moderate to Severe Psoriasis.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03675542|
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : July 11, 2019
This is a 12-week treatment, singlecenter, open-label, single-arm, dose-selection, proof of concept study to determine a dosage of HSP 90 inhibitor (CUDC-305) that is tolerable and demonstrates preliminary efficacy for use in future efficacy Phase 2 trials. Male or female subjects aged 18 years or older with moderate to severe plaque psoriasis will be included in this study.
Objectives are to determine the efficacy, safety and tolerability of CUDC-305 in patients with moderate to severe psoriasis.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: CUDC-305||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open-label, singlecenter, single-arm, dose-selection, proof of-concept study|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Open-label, Single-arm, Dose-selection, Proof-of-concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (CUDC-305) in the Treatment of Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Study medication
HSP90 inhibitor (CUDC-305)
Dose-selection treatment with HSP90 inhibitor (CUDU-305)
- Change from baseline in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Week 12 ]Clinical severity score
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Week 12 ]TEAEs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675542
|Contact: Anne Bregnhøj, MD, PhD||+45 2183 firstname.lastname@example.org|
|Contact: Bregnhøj||+45 2183 email@example.com|
|Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Anne Bregnhøj, PhD firstname.lastname@example.org|