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Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

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ClinicalTrials.gov Identifier: NCT03587194
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Psoriasis Treatment Center of Central New Jersey

Brief Summary:
Patients with moderate to severe plaque psoriasis will be treated with Otezla BID. At week 8, non responders will be discontinued, partial responders will be given add-on Enstilar QD for 4 weeks and PASI 75 responders will remain on Otezla monotherapy through week 16.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Otezla Phase 4

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Otezla
Otezla BID
Drug: Otezla
Otezla 30mg BID




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adult ≥ 18 years of age;
  2. Diagnosis of chronic plaque-type psoriasis
  3. Moderate to severe plaque type psoriasis as defined at baseline by:

    • PGA score of 3 or greater
    • BSA affected by plaque-type psoriasis of 10% or greater
    • PASI ≥ 12
  4. Able and willing to give written informed consent prior to performance of any study-related procedures
  5. Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

Exclusion Criteria:

  1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
  2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
  3. Subjects who previously used any biologic agent for psoriasis.
  4. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
  5. Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
  6. Patient received UVB phototherapy within 2 weeks of Baseline.

Information from the National Library of Medicine

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


Contacts
Contact: Jerry Bagel, MD 6094434500 dreamacres1@aol.com
Contact: Elise Nelson 6094434500 enelson@windsordermatology.com

Locations
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    jdelvalle@windsordermatology.com   
Contact: Elise Nelson    6094434500    enelson@windsordermatology.com   
Principal Investigator: Jerry Bagel, MD         
Sub-Investigator: Brian Keegan, MD, PhD         
Sub-Investigator: David Nieves, MD         
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
Celgene Corporation

Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT03587194     History of Changes
Other Study ID Numbers: AP-CL-PSOR-PI-13156
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Calcipotriene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents