This Study is Being Conducted to Evaluate the Safety, Tolerability, and Efficacy of KD025 Administered Orally for 16 Weeks to Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy.
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Psoriasis | Drug: KD025 Drug: Placebo tablet | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
- Psoriasis Area Severity Index (PASI) 75 [ Time Frame: 16 weeks ]To assess the number of subjects that reach PASI 75 after 16 weeks of dosing with various regimens of KD025 compared to placebo.
- Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 16 weeks ]To evaluate the safety and tolerability of KD025 at various regimens when administered for 16 weeks to subjects with moderate to severe chronic plaque psoriasis.
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2016 |
| Estimated Primary Completion Date: | August 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: KD025 200 mg QD (Once Daily)
200 mg KD025 QD (subjects will receive one KD025 200 mg and one matching placebo tablet in the morning and a matching placebo in the evening).
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Drug: KD025
Other Name: SLx-2119
|
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Experimental: KD025 200 mg BID (Twice Daily)
200 mg KD025 BID (subjects will receive one KD025 200 mg 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 (Once Daily)
400 mg KD025 QD (subjects will receive two KD025 200 mg tablets in the morning and a matching placebo in the evening).
|
Drug: KD025
Other Name: SLx-2119
|
|
Experimental: KD025 600mg/day
600 mg/day KD025 (subjects will receive 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
Placebo (subjects will receive two matching placebo tablets in the morning and one matching placebo tablet in the evening).
|
Drug: Placebo tablet |
Detailed Description:
This study will be performed in adult male and female subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Study drug will be orally administered in a double-blind fashion for 16 weeks in order to evaluate efficacy through 16 weeks of treatment. Approximately 150 subjects will be randomly assigned to 1 of 5 dose cohorts:
- 200 mg KD025 once daily (QD)
- 200 mg KD025 BID
- 400 mg KD025 QD
- 600 mg/day KD025 (administered as 400 mg in the morning and 200 mg in the evening)
- Placebo BID
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult subjects between the ages of 18 and 65 years
- Able to provide written ICF prior to the performance of any study specific procedures
- Has a diagnosis of moderate to severe chronic plaque psoriasis and is a candidate for systemic therapy or phototherapy
- Has a PASI of ≥ 12 at screening and prior to the first dose of study drug, confirmed at Week 1 (Day 1)
- >/= 10% PASI body surface area involvement at screening and prior to the first dose of study drug, confirmed at Week 1 (Day 1)
- Willing to avoid tanning devices
-
Have adequate bone marrow function:
- Absolute neutrophil count (ANC) > 1500/mm3
- Hemoglobin > 9.0 g/dL
- Platelets > 100,000/mm3
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Have 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 have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression
- Women of childbearing potential (i.e., menstruating women) must have 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 agree 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 includes (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; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) a vasectomized partner
- For male patients who are sexually active and who are 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:
- Has non-plaque or drug-induced (antimalarials, lithium) psoriasis (If subject is taking angiotensin II receptor blockers or beta blockers doses must be stable for 6 months prior to study entry)
- Use of systemic corticosteroids within 12 weeks prior to study entry
- Use topical corticosteroids except to the face, groin, or scalp
- Use of methotrexate, retinoids (such as acitretin), or calcineurin inhibitors (such as cyclosporine) within 4 weeks prior to study entry
- Using phototherapy within 4 weeks prior to study entry
- Using biologic therapies, including antibodies to IL-17, anti-TNFα, anti-IL-12 & -23, within 3 months prior to study entry
- Current use of an inhibitor or inducer of CYP3A4
- Has an active viral, fungal, or bacterial skin infection (other than nail fungal infection).
- Is a pregnant or lactating woman
- Has a history of GI surgery including any bariatric surgery, or any gastrointestinal condition that might interfere with drug absorption
- Currently participating in another study with an investigational drug or within 28 days or 5 half-lives of the investigational drug (whichever is longer) of study entry
- Has 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 equals one "drink" unit. One unit equals 1 ounce of distilled spirits, one 12-ounce beer, or one 4-ounce glass of wine
- Has QTc(F) interval (QT interval data corrected using Fridericia's formula) of > 450 msec (average of 3 readings) during screening
- Has 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
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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 be interviewed regarding use of alcohol, have levels repeated and participation in the study should be discussed with the medical monitor.)
- Renal disease and/or serum creatinine > 1.5 × ULN at screening
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02852967
| United States, Arizona | |
| Alliance Dermatology and Mohs Center | Recruiting |
| Phoenix, Arizona, United States, 85032 | |
| Contact: Sasha S Jazayeri, MD drjaz@yahoo.com | |
| United States, California | |
| University of California, Irvine - Dermatology Clinical Research Center | Recruiting |
| Irvine, California, United States, 92697 | |
| Contact: Patty Summerville 949-824-7103 | |
| Dermatology Research Associates | Recruiting |
| Los Angeles, California, United States, 90045 | |
| Contact: Kayla Travers ktravers@drsofen.com | |
| United States, Florida | |
| Renstar Medical Research | Recruiting |
| Ocala, Florida, United States, 34471 | |
| Contact: Carol Jackson 352-629-5800 carol.jackson@renstar.net | |
| United States, Indiana | |
| Dawes Fretzin Dermatology Group | Recruiting |
| Indianapolis, Indiana, United States, 46256 | |
| Contact: Dottie Craig, RNC/NP DCraig2@ecommunity.com | |
| Dermatology Specialists Research | Recruiting |
| New Albany, Indiana, United States, 40202 | |
| Contact: Anna Duncan 502-373-2849 aduncan@dsrtrials.com | |
| United States, Kentucky | |
| Dermatology Specialists Research | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Lindsay Chaput 502-585-9059 lchaput@dsrtrials.com | |
| United States, Massachusetts | |
| Metro Boston Clinical Partners | Recruiting |
| Brighton, Massachusetts, United States, 02135 | |
| Contact: Mark Amster, MD 781-444-0900 mark_amster@yahoo.com | |
| United States, New Jersey | |
| Psoriasis Treatment Center of Central New Jersey | Recruiting |
| East Windsor, New Jersey, United States, 08520 | |
| Contact: Jalyssa Delvalle jdelvalle@windsordermatology.com | |
| United States, New York | |
| Sadick Research Group | Recruiting |
| New York, New York, United States, 10075 | |
| Contact: Krista Bohnert 212-772-7242 kbohnert@sadickdermatology.com | |
| United States, North Carolina | |
| Dermatology Consulting Services | Recruiting |
| High Point, North Carolina, United States, 27262 | |
| Contact: Zoe Draelos, MD 336-841-2040 zdraelos@northstate.net | |
| United States, Oregon | |
| Oregon Dermatology and Research Center | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: Gabriela Bosley 503-226-3376 ext 27 ODRC@phoeberichmd.com | |
| United States, Tennessee | |
| Tennessee Clinical Research Center | Recruiting |
| Nashville, Tennessee, United States, 37215 | |
| Contact: Research Office 615-383-9660 | |
| United States, Texas | |
| Suzanne Bruce and Associates | Recruiting |
| Katy, Texas, United States, 77056 | |
| Contact: Angie Deibler 713-985-0210 ext 152 | |
| Austin Institute for Clinical Research | Recruiting |
| Pflugerville, Texas, United States, 78660 | |
| Contact: Melanie Carter-Ratcliff 512-279-2545 melanie@atxresearch.com | |
| United States, Virginia | |
| Virginia Clinical Research | Withdrawn |
| Norfolk, Virginia, United States, 23502 | |
More Information
| Responsible Party: | Kadmon Corporation, LLC |
| ClinicalTrials.gov Identifier: | NCT02852967 History of Changes |
| Other Study ID Numbers: |
KD025-211 |
| Study First Received: | July 29, 2016 |
| Last Updated: | June 23, 2017 |
| 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:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on July 17, 2017


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