Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque 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: NCT02527421
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Tracking Information
First Submitted Date  ICMJE August 10, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE August 19, 2015
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Participants with HPA axis suppression at Day15 [ Time Frame: Day 15 ]
    Number of participants with HPA axis suppression at Day15, by measuring the level of cortisol in the blood after ACTH stimulation test
  • Participants with HPA axis suppression at Day 29 [ Time Frame: Day 29 ]
    Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • Number of participants with HPA axis suppression at Day15, by measuring the level of cortisol in the blood after ACTH stimulation test [ Time Frame: Day 15 ]
  • Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test [ Time Frame: Day 29 ]
Change History Complete list of historical versions of study NCT02527421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05%
Brief Summary To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Detailed Description To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE Drug: DFD01 Spray
DFD-01 (betamethasone dipropionate) Spray, 0.05%
Other Name: betamethasone
Study Arms  ICMJE
  • Experimental: DFD01 Spray Group 1
    DFD01 spray, twice daily, 15 days
    Intervention: Drug: DFD01 Spray
  • Experimental: DFD01 Spray Group 2
    DFD01 spray, twice daily, 29 days
    Intervention: Drug: DFD01 Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2015)
75
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must weigh at least 55 pounds
  2. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
  3. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
  4. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
  5. Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
  2. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
  3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.
  4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
  5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
  6. Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
  7. Subjects who have an abnormal sleep schedule or work overnight.
  8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
  9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carmela Fritz 6093759929 cfritz@promiuspharma.com
Contact: Lauren Williams 609-375-9678 LWilliams@drreddys.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02527421
Other Study ID Numbers  ICMJE DFD01-CD-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Promius Pharma, LLC
Study Sponsor  ICMJE Promius Pharma, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Srinivas Sidgiddi, MD Dr. Reddy's Laboratories, Inc
PRS Account Promius Pharma, LLC
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP