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Trial record 1 of 1 for:    KD025-209
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KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT03919799
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Tracking Information
First Submitted Date  ICMJE November 21, 2018
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE July 9, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
CRISS Response at Week 24 [ Time Frame: 24 weeks ]
To evaluate the efficacy of KD025 compared to placebo for the Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 24.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • CRISS Response at Week 52 [ Time Frame: 52 weeks ]
    To assess the Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) for each group at Week 52.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 using the Modified Rodnan Skin Score (mRSS). Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome)
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 using Forced Vital Capacity (FVC).
  • Quality of life and functional ability assessed by questionnaire [ Time Frame: 24 weeks ]
    To assess the impact of KD025 on quality of life at Week 24 using the Health Assessment Questionnaire-Disability Index (HAQ-DI). To determine the validity and usefulness of a modified Health Assessment Questionnaire (HAQ) for measurement of disease status and changes in disease status over time in patients with systemic sclerosis (SSc). The HAQ-DI scale consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicates the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 for physicians global assessment using visual analog scale to assess overall health between 0-10. A 0 score being extremely poor and 10 being excellent.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 for patients global assessment using visual analog scale to assess overall health between 0-10. A 0 score being extremely poor and 10 being excellent.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 for Scleroderma Health Assessment Questionnaire- Disability Index (SHAQ-DI). SHAQ-DI assesses five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items are developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item is rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items are: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Modified Rodnan Skin Score (mRSS). Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome)
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Forced Vital Capacity (FVC).
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Health Assessment Questionnaire-Disability Index (HAQ-DI). To determine the validity and usefulness of a modified Health Assessment Questionnaire (HAQ) for measurement of disease status and changes in disease status over time in patients with systemic sclerosis (SSc). The HAQ-DI scale consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicates the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for physicians global assessment.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for patient global assessment.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI). SHAQ-DI assesses five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items are developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item is rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items are: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
  • Lung Fibrosis Change Assessment via HRCT [ Time Frame: Baseline, Week 24, and Week 52 ]
    To assess changes in lung fibrosis, via high resolution computerized tomography (HRCT), performed at baseline, Weeks 24 and Week 52 only in subjects with Interstitial lung disease (ILD) at screening.
  • Plasma Concentration Analysis [ Time Frame: Pre-dose and 3 hours post-dose at Week 4, and Week 8 ]
    To measure plasma concentration of KD025 on Weeks 4 and 8 immediately prior to KD025 dosing and 3 hours post-dose.
  • Adverse Event Review [ Time Frame: Through study completion, an average of 52 weeks ]
    To assess the safety of KD025 compared to placebo in subjects with Diffuse Cutaneous Systemic Sclerosis by examining the percentage of subjects with treatment-emergent adverse events (CTCAE v5.0) in subjects with diffuse cutaneous systemic sclerosis
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • CRISS Response at Week 52 [ Time Frame: 52 weeks ]
    To assess the Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) for each group at Week 52.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 using the Modified Rodnan Skin Score (mRSS). Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome)
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 using Forced Vital Capacity (FVC).
  • Quality of life and functional ability assessed by questionnaire [ Time Frame: 24 weeks ]
    To assess the impact of KD025 on quality of life at Week 24 using the Health Assessment Questionnaire-Disability Index (HAQ-DI). To determine the validity and usefulness of a modified Health Assessment Questionnaire (HAQ) for measurement of disease status and changes in disease status over time in patients with systemic sclerosis (SSc). The HAQ-DI scale consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicates the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 for physicians global assessment using visual analog scale to assess overall health between 0-10. A 0 score being extremely poor and 10 being excellent.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 for patients global assessment using visual analog scale to assess overall health between 0-10. A 0 score being extremely poor and 10 being excellent.
  • Efficacy of KD025 in Comparison to Placebo at Week 24 [ Time Frame: 24 weeks ]
    To evaluate the efficacy of KD025 compared to placebo at Week 24 for Scleroderma Health Assessment Questionnaire- Disability Index (SHAQ-DI). SHAQ-DI assesses five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items are developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item is rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items are: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Modified Rodnan Skin Score (mRSS). Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0-3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome)
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Forced Vital Capacity (FVC).
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Health Assessment Questionnaire-Disability Index (HAQ-DI). To determine the validity and usefulness of a modified Health Assessment Questionnaire (HAQ) for measurement of disease status and changes in disease status over time in patients with systemic sclerosis (SSc). The HAQ-DI scale consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicates the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for physicians global assessment.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for patient global assessment.
  • Efficacy of KD025 in Comparison to Placebo at Week 52 [ Time Frame: 52 weeks ]
    To evaluate the efficacy of KD025 at Week 52 compared to baseline for subjects randomized to KD025 for Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI). SHAQ-DI assesses five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items are developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item is rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items are: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
  • Lung Fibrosis Change Assessment via HRCT [ Time Frame: Baseline, Week 24, and Week 52 ]
    To assess changes in lung fibrosis, via high resolution computerized tomography (HRCT), performed at baseline, Weeks 24 and Week 52 only in subjects with Interstitial lung disease (ILD) at screening.
  • Plasma Concentration Analysis [ Time Frame: Pre- and post- dose at Week 4, and Week 8 ]
    To measure plasma concentration of KD025 on Weeks 4 and 8 immediately prior to KD025 dosing and 3 hours post-dose.
  • Adverse Event Review [ Time Frame: Through study completion, an average of 52 weeks ]
    To assess the safety of KD025 compared to placebo in subjects with Diffuse Cutaneous Systemic Sclerosis by examining the percentage of subjects with treatment-emergent adverse events (CTCAE v5.0) in subjects with diffuse cutaneous systemic sclerosis
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2019)
  • Biomarker Analysis [ Time Frame: Baseline, Week 24, and Week 52 ]
    To evaluate changes in concentration of collagen biomarkers in serum indicative of extracellular matrix turnover from baseline to week 24 and week 52.
  • Histology on skin biopsy samples [ Time Frame: Baseline, Week 24, and Week 52 ]
    Hematoxylin and eosin (H&E) stain on skin biopsy samples taken from subjects at baseline, Week 24 and optionally at Week 52.
  • Gene Expression on skin biopsy samples [ Time Frame: Baseline, Week 24, and Week 52 ]
    To assess differential gene expression of markers associated with inflammation and fibrosis from skin biopsies taken from subjects at baseline, Week 24 and optionally at Week 52.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
Official Title  ICMJE A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis
Brief Summary Phase II Diffuse Cutaneous Systemic Sclerosis study seeking to evaluate the efficacy and safety of KD025. Upon eligibility confirmation, a total of sixty (60) adult subjects will be enrolled and randomized into three (3) groups (1:1:1) to either receive orally administered KD025 (two doses) or matched placebo for 28 weeks. The study will be double-blinded for the first 28 weeks followed by an open label extension period of 24 weeks. After un-blinding, the subjects on KD025 will continue on the same KD025 dose whereas the subjects in the placebo group will be re-randomized to one of the KD025 doses.
Detailed Description

Systemic sclerosis (SSc) is a chronic autoimmune disease that causes widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. Limited cutaneous systemic sclerosis is primarily cutaneous, affecting the hands, arms, and face. Diffuse cutaneous systemic sclerosis (dcSSc) is a more serious manifestation of the disease and is often rapidly progressive, not only involving the skin, but also involving internal organs including kidney, heart, and lungs.

Subjects who have signed an IRB/IEC-approved informed consent form and met all of the inclusion/exclusion criteria will be enrolled. A total of sixty (60) subjects will be randomized into three (3) groups (1:1:1) to receive orally administered KD025 200 mg once daily (QD; n = 20), KD025 200 mg twice daily (BID; n = 20), or matched placebo (n = 20) for 28 weeks. The study will be double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks. After unblinding, the subjects in Group 1 and 2 will continue on the same KD025 dose whereas the subjects in the placebo group will be re-randomized to one of the KD025 doses (200 mg QD or 200 mg BID) in 1:1 fashion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Three (3) groups (1:1:1) to receive orally administered KD025 200 mg QD (n = 20), KD025 200 mg BID (n = 20), or matched placebo (n = 20) for twenty-eight (28) weeks. The study will be double-blinded for the first twenty-eight (28) weeks followed by an open-label extension of twenty-four (24) weeks. After unblinding, the subjects in Group 1 and 2 will continue on the same KD025 dose whereas the subjects in the placebo group will be re-randomized to one of the KD025 doses (200 mg QD or 200 BID) in 1:1 fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-Blinded for the first 28 Weeks
Primary Purpose: Treatment
Condition  ICMJE
  • System; Sclerosis
  • Diffuse Cutaneous Systemic Sclerosis
Intervention  ICMJE
  • Drug: KD025
    ROCK-2 Inhibitor
  • Drug: Placebo
    Inactive substance
Study Arms  ICMJE
  • Experimental: Group 1
    20 subjects will be randomized to receive orally administered KD025 200 mg daily, double-blinded for the first 28 weeks. Subjects will then will be unblinded, and continue on the same KD025 dose for the remaining 24 weeks.
    Interventions:
    • Drug: KD025
    • Drug: Placebo
  • Experimental: Group 2
    20 subjects will be randomized to receive orally administered KD025 200 mg twice a day, double-blinded for the first 28 weeks. Subjects will then will be unblinded, and continue on the same KD025 dose for the remaining 24 weeks.
    Interventions:
    • Drug: KD025
    • Drug: Placebo
  • Placebo Comparator: Group 3
    20 subjects will be randomized to receive orally administered matched placebo, double-blinded for the first 28 weeks. Subjects will then will be unblinded, and re-randomized to one of the KD025 doses (200 mg daily or 200 twice a day) in a 1:1 fashion.
    Interventions:
    • Drug: KD025
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female subjects ≥ 18 years old with the diagnosis of dcSSc according to the 2013 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria
  2. Must have disease duration (defined as interval from first non-Raynaud disease manifestation) of ≤ 5 years
  3. Must have mRSS of ≥ 15 but ≤ 35
  4. Active disease defined as any of the following within the 6 months prior to screening:

    1. Increase in mRSS by ≥ 3 units
    2. Increase in mRSS by ≥ 2 units with involvement of one new body area
    3. Involvement of two new body areas
    4. Symptoms indicative of skin activity such as severe cutaneous itching or burning
  5. Must be receiving a stable dose of mycophenolate mofetil (≤ 3 gm/day) or methotrexate (≤ 25 mg/week) for at least 4 weeks
  6. Adequate organ and bone marrow functions evaluated during the twenty-eight (28) days prior to enrollment as follows:

    1. Absolute neutrophil count ≥ 1.5 × 10^9/L
    2. Platelet count ≥ 100 × 10^9/L
    3. Total bilirubin ≤ 1.0 × upper limit of normal (ULN);
    4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal limits; and
    5. Serum creatinine ≤ 1.5 × ULN.
  7. 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 twelve (12) months. However, women who have been amenorrheic for twelve (12) or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.

    1. 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.
    2. 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 three (3) months after their last dose of study drug. Effective birth control includes (i) IUD plus one barrier method; (ii) on stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method; or (iii) two barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm), or a vasectomized partner.
  8. For male patients who are sexually active and who are partners of premenopausal women: agreement to use two (2) forms of contraception as in criterion number 7 above during the treatment period and for at least three (3) months after the last dose of study drug.
  9. Male Subjects must not donate sperm for three (3) months after last dose of study drug.
  10. Able to provide written informed consent prior to the performance of any study-specific procedures.

Exclusion Criteria:

  1. Subject has QTcF >450 ms
  2. Female subject who is pregnant or breastfeeding;
  3. Participated in another study with an investigational drug within twenty-eight (28) days of study entry (for studies involving biologics, within three half-lives of the biologic);
  4. 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;
  5. Chronic heart failure with New York Heart Association Class II,III or IV;
  6. Positive human immunodeficiency virus (HIV) test;
  7. Active hepatitis C virus (HCV), hepatitis B virus (HBV), or positive tuberculin skin test;
  8. Diagnosed with any malignancy within three (3) years of enrollment, with the exception of basal cell or completely resected squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection;
  9. Has had previous exposure to KD025 or known allergy/sensitivity to KD025, or any other ROCK2 inhibitor;
  10. Scleroderma renal crisis within four (4) months prior to enrollment;
  11. FVC ≤ 50%. Predicted.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicholas Messier 724-778-6150 nicholas.messier@kadmon.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919799
Other Study ID Numbers  ICMJE KD025-209
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kadmon Corporation, LLC
Study Sponsor  ICMJE Kadmon Corporation, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kadmon Corporation, LLC
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP