Clinical trial: Relieving Chronic Itch: Oral Medication (NCT02909569)

Eligibility criteria:
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:

          1. Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic
             dermatitis, psoriasis, etc.)

          2. Patients with a prior diagnosis of excoriation disorder

          3. Use of topical treatments for CIP (other than bland emollients) within 1 week of
             baseline

          4. Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable
             corticosteroids, methotrexate, cyclosporine, mycophenolat mofetil, azathioprine)
             within 4 weeks of baseline

          5. 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

          6. Unwilling or unable to follow medication restrictions or unwilling or unable to
             sufficiently washout from use of restricted medication

          7. Use of any prohibited medications (see Section 5.8) within 14 days or 5 half-lives
             (whichever is longer) of the baseline visit

          8. 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)

          9. Active malignancy

         10. 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

         11. History (including family history) or current evidence of congenital long QT syndrome
             or known acquired QT prolongation

         12. Exposure to any investigational medication, including placebo, within 60 days of the
             Baseline Visit

         13. History of intolerance and/or hypersensitivity to medications similar to INCB039110
             (e.g., Xeljanz)

         14. Participation in a previous INCB39110 trial

         15. 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

         16. Anyone affiliated with the site or sponsor and/or anyone who may consent under duress

         17. 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

         18. Subjects taking potent systemic CYP3A4 inhibitors or fluconazole within 2 weeks or 5
             half-lives, whichever is longer, before the baseline visit

         19. Subjects who have previously received JAK inhibitors, systemic or topical (e.g.
             ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib and pacritinib)

         20. Women who were pregnant or breastfeeding within 4 months before screening.

         21. Current or recent history (< 30 days before screening and/or < 45 days before
             randomization) of a clinically meaningful bacterial, fungal, parasitic, or
             mycobacterial infection

         22. 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

         23. 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

         24. Subjects who have received systemic chemotherapy at any time

         25. Subjects who anticipate receiving a live or live-attenuated vaccination from screening
             through the final follow-up visit

         26. Subjects who, in the opinion of the investigator, are unable or unlikely to comply
             with the administration schedule and study evaluations

             -
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction