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NCT02651714

Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Completed Phase 2 Results posted Last updated 13 June 2024
What this trial tests

Phase 2 trial testing Tradipitant in Atopic Dermatitis in 168 participants. Completed in 4 August 2017.

Timeline
19 January 2016
Primary endpoint
4 August 2017
4 August 2017

Quick facts

Lead sponsorVanda Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment168
Start date19 January 2016
Primary completion4 August 2017
Estimated completion4 August 2017
Sites28 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanda Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score Primary · 56 days

Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm).

GroupValue95% CI
Tradipitant-41.5± 3.89
Placebo-35.8± 4.03

Adverse events — posted to ClinicalTrials.gov

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 100 days) regardless of seriousness or relationship to investigational product.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tradipitant
Serious: 0/83 (0%)
Deaths: 0/83
Placebo
Serious: 0/82 (0%)
Deaths: 0/82
Other adverse events (1 terms — click to expand)

ReactionSystemTradipitantPlacebo
Dermatitis atopicSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02651714 adverse events section.

Sponsor's own description

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.
    Facheris P, Jeffery J, Del Duca E, Guttman-Yassky E. · · 2023 · cited 150× · PMID 36928371 · DOI 10.1038/s41423-023-00992-4
  2. Neuroimmune interactions in chronic itch of atopic dermatitis.
    Yosipovitch G, Berger T, Fassett MS. · · 2020 · cited 113× · PMID 31566796 · DOI 10.1111/jdv.15973
  3. Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Hand Eczema in Adults.
    Barrett A, Hahn-Pedersen J, Kragh N, Evans E, et al · · 2019 · cited 56× · PMID 31270775 · DOI 10.1007/s40271-019-00373-y
  4. NK-1 Receptor Antagonists and Pruritus: Review of Current Literature.
    Pojawa-Gołąb M, Jaworecka K, Reich A. · · 2019 · cited 30× · PMID 31190215 · DOI 10.1007/s13555-019-0305-2
  5. Looking forward to new targeted treatments for chronic spontaneous urticaria.
    Kocatürk E, Maurer M, Metz M, Grattan C. · · 2017 · cited 29× · PMID 28078079 · DOI 10.1186/s13601-016-0139-2
  6. Neural Regulation of Innate Immunity in Inflammatory Skin Diseases.
    Huang X, Li F, Wang F. · · 2023 · cited 10× · PMID 37259392 · DOI 10.3390/ph16020246
  7. A Therapeutic Renaissance - Emerging Treatments for Atopic Dermatitis.
    Na CH, Baghoomian W, Simpson EL. · · 2020 · cited 8× · PMID 32419031 · DOI 10.2340/00015555-3515
  8. The myeloid switch: immune drivers in atopic dermatitis - roles in pathogenesis and emerging therapeutic targeting.
    Kupschke E, Schenk M. · · 2025 · cited 3× · PMID 40661941 · DOI 10.3389/fimmu.2025.1608338

Verify or expand the search:

Other trials of Tradipitant

Trials testing the same drug.

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

Other Vanda Pharmaceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02651714.

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