A Phase lb, Double­Blind, Randomized, Placebo- Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Repeated Doses of KPL-716.

  • STATUS
    Recruiting
Updated on 28 February 2019

Summary

Phase III Atopic Dermatitis trial

 

Details
Condition Eczema (Atopic Dermatitis)
Clinical Study IdentifierTX218052
Last Modified on28 February 2019

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females, of any ethnic origin
to 65 years of age, inclusive
Body mass index between 18.0 and 36.0 kg/m2, inclusive, at Screening Visit 1
Have a physician-documented diagnosis of atopic dermatitis. Duration of disease must be at least 1 year. The study dermatologist or the study allergist/immunologist confirms the diagnosis of atopic dermatitis (based on American Academy of Dermatology Consensus Criteria Eichenfield 2014, 0). The duration of disease (at least 1 year) can be documented as affirmed by the subject
Have a physician-documented diagnosis of moderate to severe disease, defined as
IGA of 3 or 4, and body surface area (BSA) involvement of 10% or more at Screening Visit 1, Screening Visit 2 and Day 0 and
Eczema Area and Severity Index (EASI) score > 12 at Screening Visit 1, Screening Visit 2 and Day 0
Duration of disease severity must be at least 3 months before Screening Visit 1. The study dermatologist or the study allergist/immunologist documents adequate disease severity based on IGA, BSA and EASI. The duration of disease severity (at least 3 months) can be documented as affirmed by the subject
Have Pruritus NRS ≥ 7 at Screening Visit 1 and ≥ 5 on Day 0. There must be no more than one Pruritus NRS value below 4 between Screening Visit 2 and Day 0
Must agree to use the prescribed emollient twice daily and to follow the study protocol with respect to concomitant medications from Screening Visit 1 until at least Day 147
Willingness to remain on selected stable concomitant medications, defined as not starting new medication(s) or changing dosage(s), or stopping medication(s) within 30 days prior to Day 0 unless deemed acceptable by the Investigator in consultation with the Sponsor. Willingness to remain on prior regimen from Screening until Study Completion except as stipulated by the protocol or unless deemed acceptable by the Investigator in consultation with the Sponsor. Other adjustments may be allowable inconsultation with the subject’s physician and the Sponsor if considered not to impact subject safety or study integrity
Female subjects must be
postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or
permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or
nonpregnant, nonlactating, and having agreed to use an effective method of contraception (i.e., hormonal contraceptives, IUD or double barrier methods such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) from Screening Visit 1 until 5 months after study drug administration
Male subjects must have documented vasectomy or must agree to use double barrier methods of contraception (such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) or use condom plus hormonal contraceptives or condom plus IUD with their partners of childbearing potential from Screening Visit 1 until 7 months after study drug administration. Male subjects must agree to refrain from donating sperm from the time of dose administration until 7 months post-dose
Able to comprehend and willing to sign an Informed Consent Form and to abide by the study restrictions
In good health as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs assessment, and clinical laboratory evaluations at Screening Visit 1 and Screening Visit 2 as assessed by the Investigator in consultation with the Sponsor. Any abnormalities must be determined by the Investigator in consultation with the Sponsor to not constitute a safety risk for the subject. Subjects may have stable medical conditions that, in the Investigator’s opinion in consultation with the Sponsor, will not significantly alter the disposition of the drug, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data

Exclusion Criteria

Have used TCS or oral anti-histamines within 7 days prior to Day 0 and do not agree to refrain from these medications until Day 147 unless provided prior to that time for medical reasons by the Investigator, and study dermatologist or study allergist/immunologist in consultation with the Sponsor
Have used topical calcineurin inhibitors or topical phosphodiesterase 4 inhibitors within 7 days prior to Day 0 and do not agree to refrain from these medications until Day 147
Have used cannabinoids within 7 days prior to Day 0 and do not agree to refrain from the use of cannabinoids until Day 147
Noncompliance with the prescribed emollient as determined by the Investigator in consultation with the Sponsor
Less than 85% compliance with the Pruritus NRS tool during the screening period, unless approved by the Investigator in consultation with the Sponsor
Experience a significant flare of pruritus and/or skin eruption between Day -7 to Day 0 (prior to study drug administration) as assessed by the Investigator and the Sponsor
Receipt of any of the following treatments within the identified window prior to Day 0 and do not agree to refrain from these systemic medications during the study until Day 147
weeks for systemic corticosteroids (IV or Intramuscular or oral)
weeks for oral immunosuppressive/immunomodulating drugs (for example, cyclosporine, mycophenolate-mofetil, azathioprine, methotrexate)
weeks for phototherapy (or use of a tanning booth)
months for JAK inhibitors
months for dupilumab
half-lives (if known) or 3 months for other marketed biologics (cytokine therapy and monoclonal antibodies) or until B cells normalize in the case of rituximab 8. Have evidence of any other skin condition that would interfere with assessment of atopic dermatitis
Significant history or clinical manifestation of any metabolic, dermatological (except for atopic dermatitis), hepatic, renal, hematological, pulmonary (except asthma), cardiovascular, gastrointestinal, neurological, endocrine, rheumatologic or psychiatric disorder, as determined by the Investigator in consultation with the Sponsor
Hospitalization in the 3 months prior to Screening Visit 1
Have had a clinically significant illness within 4 weeks of Day 0, as determined by the Investigator in consultation with the Sponsor
Treatment with a live (attenuated) vaccine within 12 weeks before Day 0
Active or acute infection requiring systemic treatment (oral or IV) within 2 weeks prior to Day 0
Have an active skin infection or have had an active skin infection within 2 weeks of Screening Visit 1
Positive or intermediate results for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at Screening Visit 1
Human immunodeficiency virus infection
History of malignancy within 5 years prior to Screening Visit 1
Hospitalization for asthma within 6 months or emergency room visit for asthma within 3 months prior to Screening Visit 1. Have a history of intubation or intensive care unit care for asthma. Subjects with asthma can be enrolled if they have well controlled asthma as determined by the Investigator in consultation with the Sponsor. Inhaled corticosteroids, intranasal corticosteroids, long and short acting beta agonists are permitted as long as subject has been on a stable regimen for the 3 months prior to Screening Visit 2. An adjustment to inhaled and intranasal corticosteroids made in the period less than 3 months before Screening Visit 2 could be acceptable if approved by the Investigator in consultation with the Sponsor
Subjects with any history of anaphylaxis to biologics are excluded
Have previously taken part in or withdrawn from this study and have previously received the investigational product
Participation in a clinical study involving administration of an investigational small molecule within 3 months (or 5 half-lives, whichever is longer) prior to Day 0. Participation in a clinical study involving administration of an investigational biologic within 6 months prior to Day 0
Poor peripheral venous access that will interfere with blood sample collections
Are currently heavy users of nicotine (> ½ pack per day or nicotine equivalent/day)
Have a positive urine drug screen for opiates, methadone, cocaine, phencyclidine, or amphetamines at Screening Visit 1 or on Day 0, or positive alcohol breath test result on Day 0 (confirmed by repeat). Exceptions may be made if a subject is on a Sponsor-approved medication for a stable concomitant condition that explains the positive screen
History of alcoholism or drug/chemical abuse within 2 years prior to Day 0
Alcohol consumption of > 14 units per week. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine
Receipt of blood products within 2 months prior to Day 0
Donation of blood within 8 weeks prior to Screening Visit 1, platelets within 6 weeks prior to Screening Visit 1, or plasma within 2 weeks prior to Screening Visit 1
Use or plan to use any prescription or non-prescription medications/products within 7 days prior to Day 0, unless deemed acceptable by the Investigator in consultation with the Sponsor. Selected stable concomitant medications may be permitted during the study at the discretion of the Investigator in consultation with the Sponsor
Subjects who, in the opinion of the Investigator in consultation with the Sponsor, should not participate in this study
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