Evaluation of Add on Enstilar in Patients Using Otezla for 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: NCT03587194|
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Otezla||Phase 4|
50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 8 weeks.
At week 8, patients who achieved between PASI 25-74 response will receive 4 weeks of Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% in addition to continuing OTEZLA® therapy.
Patients who do not meet PASI 25 at week 8 will be discontinued from the study.
At week 12 (after 4 consecutive weeks of Enstilar® add on therapy), Enstilar® will be discontinued and these patients will continue Otezla® as monotherapy through week 16.
Patients who achieve PASI 75 at week 8 will remain enrolled on Otezla® monotherapy through week 16.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center Study to Evaluate the Effectiveness and Safety of Add on Enstilar® in Patients Using OTEZLA® for Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Otezla 30mg BID
- Psoriasis Area Severity Index 75 at week 12 [ Time Frame: 12 weeks ]Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)
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): NCT03587194
|Contact: Jerry Bagel, MDfirstname.lastname@example.org|
|Contact: Elise Nelsonemail@example.com|
|United States, New Jersey|
|Psoriasis Treatment Center of Central New Jersey||Recruiting|
|East Windsor, New Jersey, United States, 08520|
|Contact: Jalyssa Delvalle 609-443-4500 ext 1416 firstname.lastname@example.org|
|Contact: Elise Nelson 6094434500 email@example.com|
|Principal Investigator: Jerry Bagel, MD|
|Sub-Investigator: Brian Keegan, MD, PhD|
|Sub-Investigator: David Nieves, MD|