A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris

NCT02106195 | Completed Phase 2 Results

• 1 other identifier: KD025-205
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the safety and tolerability of 200 mg of belumosudil administered orally once daily for 28 days.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability

  To evaluate the safety and tolerability of 200 mg of belumosudil administered PO QD to subjects for treatment of psoriasis

  Up to 12 weeks:Up to 4 weeks screening (depending on signed informed consent + 4 weeks treatment + 4 weeks follow-up

Secondary Outcomes (6)

• Efficacy: Change in Overall PASI (Psoriasis Area and Severity Index) From Baseline to Week 4 and Week 8

  8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up

• Efficacy: Physician Global Assessment (PGA) at Week 4 and Week 8

  8 weeks: 4-week (28-day) treatment + 4-week (28-day) follow-up

• PK: Cmax and Cmin

  Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose

• PK: AUC(0-24) and AUC(Inf)

  Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose

• PK: Tmax

  Measured at Baseline (Day 1) and Week 4 (28 days): predose (0), 1, 2, 4, 8, and 24 hours post-dose

Study Arms (1)

Belumosudil 200 mg

EXPERIMENTAL

Belumosudil 200 mg (two 100 mg capsules) orally once daily for 28 days

Drug: Belumosudil

Interventions

Belumosudil DRUG

Also known as: Rezurock (brand name), KD025, SLx-2119

Belumosudil 200 mg

Eligibility Criteria

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

You may qualify if:

• Diagnosis of moderately severe plaque psoriasis that has been stable for 6 months and has failed at least one line of systemic therapy and is a candidate for additional systemic therapy.
• Had a PASI of ≥12
• At least 10% of body surface area that is affected by plaque psoriasis.
• Willing to avoid tanning devices or sun bathing.
• Willing to forgo systemic and topical treatments for psoriasis during the course of the study.
• Adequate bone marrow function
• Negative urine pregnancy test (for women of childbearing potential)
• Agree to use a highly effective method of birth control (\< 1% per year failure rate) during the study and for 1 month after the termination of the study.
• Willing to complete all study measurements and assessments in compliance with the protocol.

You may not qualify if:

• Non-plaque or drug-induced psoriasis
• Currently using corticosteroid or immunosuppressive therapy except for Class 5 or weaker topical corticosteroids to the face, groin, or scalp
• Using any topical therapy except for the following:
• Class 5 or weaker steroids and phototherapy for 4 weeks prior to study entry
• Immunosuppressive therapies for 4 weeks prior to study entry
• Methotrexate, acitretin, or cyclosporine for 4 weeks prior to study entry
• Biologic therapies for 3 months prior to study entry.
• Concomitant condition requiring treatment with moderate to high dose steroids in the 12 weeks prior to screening.
• Viral, fungal, or bacterial skin infection.
• Pregnant or lactating woman.
• Currently participating in another study with an investigational drug or within 28 days of study entry
• History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study
• History or presence of any of the following:
• Hepatic disease and or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 × the upper limit of normal (ULN) at screening
• Renal disease and/or serum creatinine \> 1.5xULN at screening

Sponsors & Collaborators

• Kadmon Corporation, LLC: lead

Study Sites (1)

UC Irvine Health, Dept of Dermatology

Irvine, California, 92697, United States

Location

MeSH Terms

Interventions

belumosudil; KD025

Results Point of Contact

• Title: Associate VP, Clinical Operations
• Organization: Kadmon Corporation, LLC

karin.herrera@kadmon.com

833-900-5366

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: April 2, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 23, 2022
• Results First Posted: September 13, 2021

Record last verified: 2022-03

Locations

US (1)