Chronic Plaque PsoriasisPhase 2NCT02852967
A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
A Phase 2 study testing Belumosudil in people with Chronic Plaque Psoriasis, run by Kadmon Corporation, LLC at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Belumosudil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 14 sitesUnited States
- Study dates
- 14 Sep 2016to 13 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Women of childbearing potential (i.e., menstruating women) had to have a negative urine pregnancy test (positive urine tests were to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug
- Sexually active women of childbearing potential enrolled in the study had to agree to use 2 forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control included: (a) intrauterine device plus 1 barrier method; (b) on stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method; and (c) 2 barrier methods. Effective barrier methods were male or female condoms, diaphragms, and spermicides (creams or gels that contained a chemical to kill sperm); or (d) a vasectomized partner
- For male patients who were sexually active and who were partners of premenopausal women: agreed to use 2 forms of contraception as defined above during the treatment period and for at least 3 months after the last dose of study drug
- Willing to complete all study measurements and assessments in compliance with the protocol
Who cannot join
- 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
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- 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
- History or presence of any of the following:
- ALT or AST > 2.0 × ULN at screening
- Renal disease and/or serum creatinine > 1.5 × ULN at screening
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256
University of California, Irvine - Dermatology Clinical Research Center
Irvine, California, 92697
Suzanne Bruce and Associates
Katy, Texas, 77056
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Specialists Research
Louisville, Kentucky, 40202
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Dermatology Specialists Research
New Albany, Indiana, 40202
Sadick Research Group
New York, New York, 10075
Renstar Medical Research
Ocala, Florida, 34471
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032
Oregon Dermatology and Research Center
Portland, Oregon, 97210
About this study
Official title: A Phase 2 Study, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy, Tolerability, and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy
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.
Read the detailed description
This phase 2, two-period, dose-finding, placebo-controlled study is performed on adult male and female subjects to evaluate the efficacy and safety of subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Period 1: Double-blind, Placebo-controlled Treatment Period
Approximately 110 subjects are planned to be randomly assigned to each of 5 dose cohorts in a 1:1:1:1:1 manner. Each cohort is planned to have 22 subjects who meet eligibility criteria. Subjects are treated with oral (PO) belumosudil tablets or placebo tablets as follows:
- 200 mg belumosudil once daily (QD) (Cohort 1) = one 200 mg belumosudil tablet and 1 matching placebo in the morning and 1 matching placebo in the evening
- 200 mg belumosudil twice daily (BID) (Cohort 2) = one 200 mg belumosudil tablet in the morning and one matching placebo in the morning, and one 200 mg belumosudil tablet in the evening
- 400 mg belumosudil QD (Cohort 3) = two 200 mg belumosudil tablets in the morning and one matching placebo in the evening
- 600 mg/day belumosudil (Cohort 4) = two 200 mg belumosudil tablets in the morning and one 200 mg belumosudil tablet in the evening
- Matching placebo BID (Cohort 5) = 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Subjects in each of the 5 cohorts in Period 1 are treated with study medication for a period of 16 weeks.
Note: Originally, a sample size of 36 subjects per cohort was planned to provide approximately 90% probability ≥ 1 subject in the 5 cohorts would experience an adverse event (AE) that had an underlying rate of ≥ 6% and approximately an 80% probability of ≥ 1 subject in the cohort experiencing an AE that had an underlying rate of ≥ 4%. However, due to a newly available plaque psoriasis treatment, the study is terminated early with 110 subjects.
Period 2: Open-label Treatment Period (with Belumosudil)
All subjects treated for 16 weeks, regardless of treatment with belumosudil (Cohorts 1 through 4) or placebo (Cohort 5) are given the option to receive 400 mg belumosudil QD for an additional 32 weeks (Week 16 through Week 48).
Follow-up Period
All subjects have a safety evaluation 30 days after the last dose of study drug.
Efficacy is assessed by the following scores at scheduled time points throughout the study:
- Psoriasis Area and Severity Index (PASI): Measure of psoriasis disease severity using average redness, thickness, and scaliness of lesions (each lesion graded 0 to 4), combined into single score ranging on a scale from 0 (no disease) to 72 (maximum disease)
- Physician's Global Assessment (PGA): Physician's assessment of a subject's psoriasis, relative to baseline, ranging on a scale from 1 (100% clearing of psoriasis) to 6 (poor to no clearing)
- Dermatology Life Quality Index (DLQI): Skin disease-specific instrument for assessing impact of disease on subject's quality of life ranging on a scale from 0 (no effect on subject's life) to 30 (extremely large effect on subject's life)
Safety is assessed by;
- AEs and serious AE (SAEs)
- Physical examination
- Vital sign measurements
- Clinical laboratory evaluations
- Electrocardiogram
- Reasons for discontinuation due to toxicity analyses
The maximum duration for subjects who complete Period 1 (Double-blind, Placebo-controlled) is 24 weeks (up to 4-week Screening, 16-week Period 1 treatment, and 4-week Follow-up). The maximum duration for subjects who complete Period 2 (Open-label) is 56 weeks (up to 4-week Screening, 16-week Double-blind Treatment Period, 32-week Open-label Treatment Period, and 4-week Follow-up).
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Belumosudil, Placebo
- Keywords
- Skin Diseases, Auto-Immune Diseases, Plaque, Dermatology
- Medical subject headings
- Skin Diseases, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Also called Rezurock (brand name), KD025
PlaceboDrug
Placebo tablets matching belumosudil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Belumosudil |
| Placebo | Placebo comparator | Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.]
Measured: 16 weeks
Secondary outcomes (7)
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
The mean change in the raw Psoriasis Area and Severity Index (PASI) score from baseline score to Week 16 and to Week 48 whether the subject completed 16 and 48 weeks, respectively (last observation carried forward [LOCF]), or for only those subjects who completed 16 and 48 weeks (observed), respectively. Negative values represent favorable results; positive values represent unfavorable results.
[The 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.]
Measured: 48 weeks
Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed
The percentage (%) change in the mean Psoriasis Area and Severity Index (PASI) score from baseline ore to Week 16 and to Week 48 whether the subject completed 16 and 48 weeks, respectively (last observation carried forward [LOCF]) or for only those subjects who completed 16 and 48 weeks (observed), respectively.
[The 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.]
Measured: 48 weeks
Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF
The number of subjects who had a "Clear" or "Almost Clear" assessment, using the Physician Global Assessment Scale (PGA), at Week 16 of all subjects whether they completed 16 weeks or not (last observation carried forward [LOCF]) [The PGA documents the physician's assessment of the subject's psoriasis and was assessed relative to baseline conditions. The PGA rating is from 1-6, where 1 = 100% clearing of psoriasis (clear), 5 = 0 to 24% clearing (little or no change), and 6 = worse.]
Measured: 16 weeks
Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF
The percentage (%) of subjects who had a "Clear" or "Almost Clear" assessment using the Physician Global Assessment Scale at Week 16 of belumosudil vs. placebo for all subjects whether they completed 16 weeks or not (last observation carried forward [LOCF]).
[The PGA documents the physician's assessment of the subject's psoriasis and was assessed relative to baseline conditions. The PGA rating is from 1-6, where 1 = 100% clearing of psoriasis (clear), 5 = 0 to 24% clearing (little or no change), and 6 = worse.]
Measured: 16 weeks
Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48
Changes in mean Dermatology Life Quality Index (DLQI) score from baseline at Week 16 (End of Double-blind Period) and at Week 48 (End of Study Treatment).
[The DLQI is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. DLQI scoring as measured on subject's life: 0-1 = no effect; 2-5 = small effect; 6-10 = moderate effect; 11 to 20 = very large effect; 21 to 30 = extremely large effect. Change < 0% is improvement; > 0% is worsening. The total rating ranges from 0 (no effect on a subject's life) to 30 (extremely large effect on a subject's life.]
Measured: Up to 48 weeks
Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48
Mean percentage changes in Dermatology Life Quality Index (DLQI) from baseline at Week 16 (End of Double-blind Period) and at Week 48 (End of Study Treatment).
[The DLQI is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The rating ranges from 0 (no effect on a subject's life) to 30 (extremely large effect on a subject's life.]
Measured: Up to 48 weeks
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
The number of subjects who had treatment-emergent adverse events (TEAEs), severity of TEAEs, relationship of TEAEs to study medication, serious TEAEs (SAEs), dose interruption, discontinuations, and deaths.
Treatment-emergent adverse events (TEAEs) are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
Severity: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = Death. Related to study medication is defined as possible related, probable related, and related
Measured: Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start14 Sep 2016
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852967
- Sponsor's protocol ID
- KD025-211
- Status last verified
- Mar 2022
- First submitted
- 29 Jul 2016
- Last updated
- 16 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy, Tolerability, and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy
- ClinicalTrials.gov ID
- NCT02852967
- Acronym / sponsor ID
- KD025-211
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Skin Diseases, Auto-Immune Diseases, Plaque, Dermatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase 2, two-period, dose-finding, placebo-controlled study is performed on adult male and female subjects to evaluate the efficacy and safety of subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Period 1: Double-blind, Placebo-controlled Treatment Period
Approximately 110 subjects are planned to be randomly assigned to each of 5 dose cohorts in a 1:1:1:1:1 manner. Each cohort is planned to have 22 subjects who meet eligibility criteria. Subjects are treated with oral (PO) belumosudil tablets or placebo tablets as follows:
- 200 mg belumosudil once daily (QD) (Cohort 1) = one 200 mg belumosudil tablet and 1 matching placebo in the morning and 1 matching placebo in the evening
- 200 mg belumosudil twice daily (BID) (Cohort 2) = one 200 mg belumosudil tablet in the morning and one matching placebo in the morning, and one 200 mg belumosudil tablet in the evening
- 400 mg belumosudil QD (Cohort 3) = two 200 mg belumosudil tablets in the morning and one matching placebo in the evening
- 600 mg/day belumosudil (Cohort 4) = two 200 mg belumosudil tablets in the morning and one 200 mg belumosudil tablet in the evening
- Matching placebo BID (Cohort 5) = 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Subjects in each of the 5 cohorts in Period 1 are treated with study medication for a period of 16 weeks.
Note: Originally, a sample size of 36 subjects per cohort was planned to provide approximately 90% probability ≥ 1 subject in the 5 cohorts would experience an adverse event (AE) that had an underlying rate of ≥ 6% and approximately an 80% probability of ≥ 1 subject in the cohort experiencing an AE that had an underlying rate of ≥ 4%. However, due to a newly available plaque psoriasis treatment, the study is terminated early with 110 subjects.
Period 2: Open-label Treatment Period (with Belumosudil)
All subjects treated for 16 weeks, regardless of treatment with belumosudil (Cohorts 1 through 4) or placebo (Cohort 5) are given the option to receive 400 mg belumosudil QD for an additional 32 weeks (Week 16 through Week 48).
Follow-up Period
All subjects have a safety evaluation 30 days after the last dose of study drug.
Efficacy is assessed by the following scores at scheduled time points throughout the study:
- Psoriasis Area and Severity Index (PASI): Measure of psoriasis disease severity using average redness, thickness, and scaliness of lesions (each lesion graded 0 to 4), combined into single score ranging on a scale from 0 (no disease) to 72 (maximum disease)
- Physician's Global Assessment (PGA): Physician's assessment of a subject's psoriasis, relative to baseline, ranging on a scale from 1 (100% clearing of psoriasis) to 6 (poor to no clearing)
- Dermatology Life Quality Index (DLQI): Skin disease-specific instrument for assessing impact of disease on subject's quality of life ranging on a scale from 0 (no effect on subject's life) to 30 (extremely large effect on subject's life)
Safety is assessed by;
- AEs and serious AE (SAEs)
- Physical examination
- Vital sign measurements
- Clinical laboratory evaluations
- Electrocardiogram
- Reasons for discontinuation due to toxicity analyses
The maximum duration for subjects who complete Period 1 (Double-blind, Placebo-controlled) is 24 weeks (up to 4-week Screening, 16-week Period 1 treatment, and 4-week Follow-up). The maximum duration for subjects who complete Period 2 (Open-label) is 56 weeks (up to 4-week Screening, 16-week Double-blind Treatment Period, 32-week Open-label Treatment Period, and 4-week Follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Belumosudil 200 mg QD + Placebo | Experimental | Drug: Belumosudil, Drug: PlaceboOne belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening |
| Belumosudil 200 mg BID (Twice Daily) + Placebo | Experimental | Drug: Belumosudil, Drug: PlaceboOne belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening |
| Belumosudil 400 mg QD + Placebo | Experimental | Drug: Belumosudil, Drug: PlaceboTwo belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening |
| Belumosudil 600 mg/day | Experimental | Drug: BelumosudilTwo belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening |
| Placebo | Placebo comparator | Drug: PlaceboTwo matching placebo tablets in the morning and 1 matching placebo tablet in the evening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelumosudilAlso: Rezurock (brand name), KD025 | Drug | Belumosudil 200 mg BID (Twice Daily) + Placebo, Belumosudil 200 mg QD + Placebo, Belumosudil 400 mg QD + Placebo, Belumosudil 600 mg/day |
| PlaceboPlacebo tablets matching belumosudil | Drug | Belumosudil 200 mg BID (Twice Daily) + Placebo, Belumosudil 200 mg QD + Placebo, Belumosudil 400 mg QD + Placebo, Placebo |
Primary outcome
Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed
Time frame: 16 weeks
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.]
7 secondary outcomes
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
Time frame: 48 weeks
Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed
Time frame: 48 weeks
Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF
Time frame: 16 weeks
Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF
Time frame: 16 weeks
Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48
Time frame: Up to 48 weeks
Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48
Time frame: Up to 48 weeks
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Time frame: Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belumosudil in people with Chronic Plaque Psoriasis, run by Kadmon Corporation, LLC at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.