DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

NCT02527421 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: DFD01-CD-013
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 8

Brief Summary

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later

  Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test

  End of Treatment (day 15 or day 28) with recovery 29 days later

• Participants With HPA Axis Suppression at 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

  Day 29

Study Arms (2)

DFD01 Spray Group 1

EXPERIMENTAL

DFD01 spray, twice daily, 15 days

Drug: DFD01 Spray

DFD01 Spray Group 2

EXPERIMENTAL

DFD01 spray, twice daily, 29 days

Drug: DFD01 Spray

Interventions

DFD01 Spray DRUG

DFD-01 (betamethasone dipropionate) Spray, 0.05%

Also known as: betamethasone

DFD01 Spray Group 1; DFD01 Spray Group 2

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must weigh at least 55 pounds
• Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
• Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
• Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
• 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.

You may not qualify if:

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
• Have received treatment for any type of cancer within 5 years of the Baseline Visit.
• 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).
• 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.
• Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
• Subjects who have an abnormal sleep schedule or work overnight.
• Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
• Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• Prosoft Clinical: collaborator

Study Sites (8)

Site 102

Encino, California, 91436, United States

Location

Site 104

Irvine, California, 92697-1385, United States

Location

Site 100

San Diego, California, 92123, United States

Location

Site 109

Lebanon, New Hampshire, 03756, United States

Location

Site 107

New York, New York, 10155, United States

Location

Site 106

Arlington, Texas, 76014, United States

Location

Site 101

Houston, Texas, 77030, United States

Location

Site 105

San Antonio, Texas, 78218, United States

Location

MeSH Terms

Interventions

Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Robert Babilon President
• Organization: Prosoft Clinical

b.babilon@prosoftclinical.com

484 320 2068

Study Officials

• Srinivas Sidgiddi, MD

  Dr. Reddy's Laboratories, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 19, 2015
• Study Start: August 19, 2015
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: March 7, 2024
• Results First Posted: October 21, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)