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PruritisPhase 2CIPSNCT02909569

Relieving Chronic Itch: Oral Medication

A Phase 2 study testing INCB039110 in people with Pruritis, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the effect of twice daily dose of INCB39110 in the treatment of itch in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pruritis
What is being tested?
INCB039110
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2018to 9 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
  • Leukocytes < 3 × 109/L
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  • Neutrophils < lower limit of normal
  • Lymphocytes < 0.8 × 109/L
  • Hemoglobin < 10 g/dL
  • 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:
  • Positive for hepatitis C antibody test (anti-HCAbF) with detectable RNA
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb);
  • 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:
  • Serum creatinine > 1.5 mg/dL;
  • 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
  • -

About this study

Official title: Relieving Chronic Itch : Oral Medication

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

Read the detailed 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.

Conditions
Pruritis
Being tested
INCB039110
Medical subject headings
Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB039110Drug

    All subjects will receive 400 mg PO QD for 12 weeks. If no clinical response after four weeks, dose will be increased to 600 mg PO QD. Total duration of subject participation will be six study visit over 20 weeks.

Study groups in NCT02909569
Study groupRoleWhat they receive
INCB039110ExperimentalINCN039110 400 mg QD for 20 weeks. Subjects without clinical response after four weeks will increase to 600mg QD.
Receives: Drug: INCB039110

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numerical Rating Scale (NRS) itch score

    Absolute change from Baseline NRS itch score to week 12

    Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startAug 2018 (estimated)
  3. Primary completion9 Oct 2018
  4. Study completion9 Oct 2018

Why it stopped: Contract could not be agreed on.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909569
Sponsor's protocol ID
CIP9110
Acronym
CIPS
Status last verified
May 2019
First submitted
19 Sep 2016
Last updated
13 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCB039110 in people with Pruritis, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Rating Scale (NRS) itch score (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.

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