Relieving Chronic Itch: Oral Medication

NCT02909569 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CIP9110
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pruritis

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) itch score

  Absolute change from Baseline NRS itch score to week 12

  Baseline to 12 weeks

Study Arms (1)

INCB039110

EXPERIMENTAL

INCN039110 400 mg QD for 20 weeks. Subjects without clinical response after four weeks will increase to 600mg QD.

Drug: INCB039110

Interventions

INCB039110 DRUG

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.

INCB039110

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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);

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Pruritus

Interventions

INCB039110

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Kim, MD/MTR

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: August 1, 2018
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share