Relieving Chronic Itch: Oral Medication (CIPS)

The Washington University

Status and phase

Withdrawn

Phase 2

Conditions

Pruritis

Treatments

Drug: INCB039110

Study type

Interventional

Funder types

Other

Identifiers

NCT02909569

CIP9110

Details and patient eligibility

About

This study evaluates the effect of twice daily dose of INCB39110 in the treatment of itch in adults.

Full description

Chronic idiopathic itch accompanies low-grade skin inflammation. These inflammatory features are associated with cytokine production which signal through the common JAK1-STAT pathway. It is therefore theorized that a selective JAK1 inhibitor such as INCB039110 may provide relief of itch symptom.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and non-pregnant, non-lactating female subjects aged 18 years or older
Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both Screening and Baseline
Diagnosis of CIP for at least 6 weeks prior to screening
Willingness to avoid pregnancy or fathering of children
Ability and willingness to provide written informed consent
Willing and able to comply with all study requirements and restrictions
Willing to not participate in any other interventional trial for the duration of their participation
Subjects must be in good health as determined by medical history, physical examination, electrocardiogram, clinical laboratory tests and vital signs
Failure of a course 2-week course of treatment with topical triamcinolone 0.1% ointment BID
Histopathological demonstration of skin dermal edema, eosinophils, mast cell activation or lymphocytic infiltration

Exclusion criteria

Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic dermatitis, psoriasis, etc.)
Patients with a prior diagnosis of excoriation disorder
Use of topical treatments for CIP (other than bland emollients) within 1 week of baseline
Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolat mofetil, azathioprine) within 4 weeks of baseline
Subjects with cytopenias at screening, defined as:
1. Leukocytes < 3 × 109/L
2. Neutrophils < lower limit of normal
3. Lymphocytes < 0.8 × 109/L
4. Hemoglobin < 10 g/dL
5. Platelets < 100 × 109/L
Unwilling or unable to follow medication restrictions or unwilling or unable to sufficiently washout from use of restricted medication
Use of any prohibited medications (see Section 5.8) within 14 days or 5 half-lives (whichever is longer) of the baseline visit
Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal gastrointestinal, endocrine or metabolic dysfunction unless currently controlled and stable, including (but not limited to) the following:
1. Positive for hepatitis C antibody test (anti-HCAbF) with detectable RNA
2. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb);
3. Positive for HIV (DUO test, p24 antigen)
Active malignancy
Subjects with a history of malignancy, except for the following adequately treated, nonmetastatic malignancies: basal cell skin cancer, squamous cell carcinomas of the skin, or in situ cervical cancer
History (including family history) or current evidence of congenital long QT syndrome or known acquired QT prolongation
Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit
History of intolerance and/or hypersensitivity to medications similar to INCB039110 (e.g., Xeljanz)
Participation in a previous INCB39110 trial
Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis or at least 1 of the following:
1. Serum creatinine > 1.5 mg/dL;
2. Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal
Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
Subjects taking potent systemic CYP3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit
Subjects who have previously received JAK inhibitors, systemic or topical (e.g. ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib and pacritinib)
Women who were pregnant or breastfeeding within 4 months before screening.
Current or recent history (< 30 days before screening and/or < 45 days before randomization) of a clinically meaningful bacterial, fungal, parasitic, or mycobacterial infection
Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg) unless approved by medical monitor/sponsor
History of alcoholism or drug addiction within 1 year before screening, or current alcohol or drug use that, in the opinion of the investigator, will interfere with the subject's ability to comply with the administration schedule and study assessments
Subjects who have received systemic chemotherapy at any time
Subjects who anticipate receiving a live or live-attenuated vaccination from screening through the final follow-up visit
Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluations