Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

NCT02601469 | Completed Phase 2 Results

• 1 other identifier: DSXS 1503
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With HPA Axis Suppression

  Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.

  28 days

Study Arms (1)

DSXS1503

EXPERIMENTAL

administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Drug: DSXS

Interventions

DSXS DRUG

twice daily for 28 days

Also known as: Active

DSXS1503

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected
• Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
• Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response

You may not qualify if:

• Patients under 2 years of age.
• Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
• Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
• Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Natalie Yantovskiy
• Organization: Taro Pharmaceuticals U.S.A. Inc

Natalie.Yantovskiy@Taro.com

+1 914-345-9001

Study Officials

• Novum Pharmaceutical Research Services

  http://www.novumprs.com/contact

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 10, 2015
• Study Start: September 4, 2015
• Primary Completion: December 29, 2016
• Study Completion: August 25, 2017
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)