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A Phase 2 Study of the Efficacy and Safety of KD025 in Subjects With Severe Chronic Plaque Psoriasis & Candidates for Systemic or Photo Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852967
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
This was a phase 2, randomized, placebo-controlled, two-period study to evaluate the safety, tolerability, and efficacy of KD025 in adult subjects with moderate to severe chronic plaque psoriasis who were candidates for systemic therapy or phototherapy..

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: KD025 Drug: Placebo tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Safety, Tolerability, and Efficacy of KD025 in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: KD025 200 mg QD (Once Daily)
Subjects received one KD025 200 mg tablet and one matching placebo tablet in the morning and a matching placebo in the evening
Drug: KD025
Other Name: SLx-2119

Experimental: KD025 200 mg BID (Twice Daily)
Subjects received one KD025 200 mg tablet and one matching placebo tablet in the morning and KD025 200 mg in the evening
Drug: KD025
Other Name: SLx-2119

Experimental: KD025 400 mg QD
Subjects received two KD025 200 mg tablets in the morning and a matching placebo in the evening
Drug: KD025
Other Name: SLx-2119

Experimental: KD025 600 mg/day
Subjects received two KD025 200 mg tablets in the morning and one KD025 200 mg tablet in the evening
Drug: KD025
Other Name: SLx-2119

Placebo Comparator: Placebo
Subjects received two matching placebo tablets in the morning and one matching placebo tablet in the evening.
Drug: Placebo tablet



Primary Outcome Measures :
  1. Efficacy: Number (%) of Subjects with a 75% Decrease in PASI by Week 16 [ Time Frame: 16 weeks ]
    The number (%) of subjects with a 75% decrease in Psoriasis Area and Severity Index Score (PASI 75) by Week 16 including: (a) descriptive statistics (n, %, 95% confidence interval [CI]) for each treatment group and (b) the difference in the percentage of subjects with a 75% decrease in PASI by Week 16 between each treatment group and the control group.


Secondary Outcome Measures :
  1. Efficacy: Week 16 Change from Baseline in PASI Scores [ Time Frame: 16 weeks ]
    Descriptive statistics (n, mean, 95% confidence interval [CI]) of Week 16 change from Baseline in Psoriasis Area and Severity Index scores summarized and tabulated by treatment group.

  2. Efficacy: Week 16 Percent Change from Baseline in PASI [ Time Frame: 16 weeks ]
    Descriptive statistics (n, mean, 95% CI) of Week 16 percent change from Baseline in Psoriasis Area and Severity Index scores summarized and tabulated by treatment group

  3. Efficacy: Improvements in PGA of "Clear" or "Almost Clear" (Excellent) at Week 16 [ Time Frame: 16 weeks ]
    The number (%) of subjects with a Physician Global Assessment change from Baseline by Week 16 including: (a) descriptive statistics (n, %, 95% CI) for each treatment group and (b) the difference in the percentage of subjects with "clear" or "almost clear" by Week 16 between each treatment group and the control group.

  4. Efficacy: Improvements in DLQI at Week 16 [ Time Frame: 16 weeks ]
    Descriptive statistics (n, mean, 95% CI) of Dermatology Life Quality Index changes from baseline to Week 16 summarized and tabulated by treatment group

  5. Efficacy: Week 48 Change from Baseline in PASI [ Time Frame: 48 weeks ]
    Descriptive statistics (n, mean, 95% CI) of Week 48 change from Baseline in Psoriasis Area and Severity Index scores summarized and tabulated by treatment group

  6. Efficacy: Week 48 Percent Change from Baseline in PASI Scores [ Time Frame: 48 weeks ]
    Descriptive statistics (n, mean, 95% CI) of Week 48 percent change from Baseline in Psoriasis Area and Severity Index score summarized and tabulated by treatment group

  7. Efficacy: Week 48 Change from Week 16 in PASI Scores [ Time Frame: 32 weeks (48 weeks minus 16 weeks) ]
    Descriptive statistics (n, mean, 95% CI) of Week 48 change from Week 16 in Psoriasis Area and Severity Index scores summarized and tabulated by treatment group

  8. Exploratory: Concentration and Change from Baseline in IL-17 Concentrations [ Time Frame: 16 weeks ]
    Descriptive statistics (n, mean, 95% CI) for concentration and change from Baseline for Interleukin-17 tablulated

  9. Safety: AEs, SAEs, PEs, VS, Laboratory, ECGs, Reasons for Discontinuation [ Time Frame: With Follow-up: 20 weeks in Part 1; 52 weeks in Part 2 ]
    • Adverse events and serious adverse events
    • Physical examinations (including weight)
    • Vital sign measurements (blood pressure, respiratory rate, temperature)
    • Clinical laboratory evaluations (hematology, chemistry, urinalysis, coagulation, lipid panel, thyroid stimulating hormone)
    • Electrocardiograms
    • Reasons for discontinuation due to toxicity



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Had a diagnosis of moderate to severe chronic plaque psoriasis and was a candidate for systemic therapy or phototherapy
  • Had a 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
  • Had adequate bone marrow function:

    • Absolute neutrophil count > 1500/mm^3
    • Hemoglobin > 9.0 g/dL
    • Platelets > 100,000/mm^3
  • Had adequate safety laboratory values:

    • Serum total bilirubin within normal limits (WNL)
    • AST and ALT < 2 × upper limit of normal (ULN)
    • Serum creatinine < 1.5 × ULN
  • Female subjects of childbearing potential had 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 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) must have had a negative urine pregnancy test (positive urine tests are 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 must have agreed to use two 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) IUD plus one 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: agreement to use two forms of contraception as in Criterion 5 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

Exclusion Criteria:

  • Had 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 of systemic corticosteroids within 12 weeks prior to study entry
  • Used topical corticosteroids except to the face, groin, or scalp
  • Used of methotrexate, retinoids (such as acitretin), or calcineurin inhibitors (such as cyclosporine) within 4 weeks prior to study entry
  • Used phototherapy within 4 weeks prior to study entry
  • Used biologic therapies, including antibodies to IL-17, anti-tumor necrosis factor-alpha, and anti-IL-12 & -23 within 3 months prior to study entry
  • Current use of an inhibitor or inducer of CYP3A4
  • Had an active viral, fungal, or bacterial skin infection (other than nail fungal infection).
  • Was a pregnant or lactating woman
  • Had a history of gastrointestinal (GI) surgery including any bariatric surgery, or any GI condition that might interfere with drug absorption
  • Was currently 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
  • Had a 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 the 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
  • Had QTc(F) interval (QT interval data corrected using Fridericia's formula) of > 450 msec (average of 3 readings) during screening
  • Had exposure to KD025 or known allergy/sensitivity to KD025 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. (Subjects with an isolated AST elevation of any magnitude, or a ratio of AST: ALT > 1.5 should have been interviewed regarding use of alcohol, have levels repeated and participation in the study should have been discussed with the medical monitor.)
    • Renal disease and/or serum creatinine > 1.5 × ULN at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852967


Locations
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United States, Arizona
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States, 85032
United States, California
University of California, Irvine - Dermatology Clinical Research Center
Irvine, California, United States, 92697
Dermatology Research Associates
Los Angeles, California, United States, 90045
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Indiana
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States, 46256
Dermatology Specialists Research
New Albany, Indiana, United States, 40202
United States, Kentucky
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Metro Boston Clinical Partners
Brighton, Massachusetts, United States, 02135
United States, New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520
United States, New York
Sadick Research Group
New York, New York, United States, 10075
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Suzanne Bruce and Associates
Katy, Texas, United States, 77056
Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Sponsors and Collaborators
Kadmon Corporation, LLC
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Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02852967    
Other Study ID Numbers: KD025-211
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kadmon Corporation, LLC:
Skin Diseases
Auto-Immune Diseases
Plaque
Dermatology
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases