A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis

NCT02852967 | Completed Phase 2 Results

• 1 other identifier: KD025-211
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 14

Brief Summary

This is a phase 2, randomized, placebo-controlled, 2-period study to evaluate the safety, tolerability, and efficacy of belumosudil in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Conditions

Chronic Plaque Psoriasis

Keywords

Skin Diseases; Auto-Immune Diseases; Plaque; Dermatology

Outcome Measures

Primary Outcomes (1)

• Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed

  The percentage of subjects who exhibited a 75% decrease or greater in the Psoriasis Area and Severity Index Score (PASI 75) whether they completed 16 weeks of treatment or not (last observation carried forward \[LOCF\]) and those who did complete 16 weeks of treatment (observed). \[PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]

  16 weeks

Secondary Outcomes (7)

• Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed

  48 weeks

• Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed

  48 weeks

• Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF

  16 weeks

• Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF

  16 weeks

• Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48

  Up to 48 weeks

Study Arms (5)

Belumosudil 200 mg QD + Placebo

EXPERIMENTAL

One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening

Drug: Belumosudil; Drug: Placebo

Belumosudil 200 mg BID (Twice Daily) + Placebo

EXPERIMENTAL

One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening

Drug: Belumosudil; Drug: Placebo

Belumosudil 400 mg QD + Placebo

EXPERIMENTAL

Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening

Drug: Belumosudil; Drug: Placebo

Belumosudil 600 mg/day

EXPERIMENTAL

Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening

Drug: Belumosudil

Placebo

PLACEBO COMPARATOR

Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening

Drug: Placebo

Interventions

Belumosudil DRUG

Also known as: Rezurock (brand name), KD025

Belumosudil 200 mg BID (Twice Daily) + Placebo; Belumosudil 200 mg QD + Placebo; Belumosudil 400 mg QD + Placebo; Belumosudil 600 mg/day

Placebo DRUG

Placebo tablets matching belumosudil

Belumosudil 200 mg BID (Twice Daily) + Placebo; Belumosudil 200 mg QD + Placebo; Belumosudil 400 mg QD + Placebo; Placebo

Eligibility Criteria

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

You may qualify if:

• Adult subjects between the ages of 18 and 65 years
• Able to provide written Informed Consent Form prior to the performance of any study-specific procedures
• Diagnosis of moderate to severe chronic plaque psoriasis and a candidate for systemic therapy or phototherapy
• PASI of ≥ 12 at screening and prior to the first dose of study drug, confirmed at Week 1 Day 1 (Baseline)
• ≥ 10% PASI body surface area involvement at screening and prior to the first dose of study drug, confirmed at Baseline
• Willing to avoid tanning devices
• Adequate bone marrow function:
• Absolute neutrophil count \> 1500/mm\^3
• Hemoglobin \> 9.0 g/dL
• Platelets \> 100,000/mm\^3
• Adequate safety laboratory values:
• Serum total bilirubin within normal limits (WNL)
• Aspartate aminotransferase (AST) and alalnine aminotransferase (ALT) \< 2 × upper limit of normal (ULN)
• Serum creatinine \< 1.5 × ULN
• Female subjects of childbearing potential with a negative pregnancy test at screening. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to prior chemotherapy, antiestrogens, or ovarian suppression

You may not qualify if:

• Non-plaque or drug-induced (antimalarials, lithium) psoriasis (If subject was taking angiotensin II receptor blockers or beta blockers doses must have been stable for 6 months prior to study entry)
• Used systemic corticosteroids within 12 weeks prior to study entry
• Used topical corticosteroids except to the face, groin, or scalp
• Used methotrexate, retinoids (such as acitretin), or calcineurin inhibitors (such as cyclosporine) within 4 weeks prior to study entry
• Phototherapy within 4 weeks prior to study entry
• Biologic therapies, including antibodies to IL-17; anti-tumor necrosis factor-alpha; and anti-IL-12 \& IL-23 within 3 months prior to study entry
• Current use of an inhibitor or inducer of CYP3A4
• Active viral, fungal, or bacterial skin infection (other than nail fungal infection).
• Pregnant or lactating woman
• History of gastrointestinal (GI) surgery including any bariatric surgery, or any GI condition that might interfere with drug absorption
• Participating in another study with an investigational drug or within 28 days or 5 half-lives of the investigational drug (whichever was longer) 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
• Regular and/or excessive use of alcohol within 2 years prior to study entry defined as alcohol intake \> 14 drinks per week in a man or \> 7 drinks per week in a woman. Approximately 10 g of alcohol equaled one "drink" unit. One unit equaled 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine
• QT interval data corrected using Fridericia's formula (QTcF) \> 450 msec (average of 3 readings) during screening
• Exposure to belumosudil or known allergy/sensitivity to belumosudil within the last 6 months prior to study entry or any other ROCK-2 inhibitor

Sponsors & Collaborators

• Kadmon Corporation, LLC: lead

Study Sites (14)

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032, United States

Location

University of California, Irvine - Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, 46256, United States

Location

Dermatology Specialists Research

New Albany, Indiana, 40202, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Suzanne Bruce and Associates

Katy, Texas, 77056, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Skin Diseases; Plaque, Amyloid

Interventions

belumosudil; KD025

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Olivier Schueller, Senior Vice President, CMC & Clinical Pharmacology
• Organization: Kadmon Corporation, LLC

olivier.schueller@kadmon.com

724-778-6170

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: September 14, 2016
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: March 16, 2022
• Results First Posted: September 13, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)