Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL
ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo)
with the primary endpoint evaluation at Week 14. During the open label extension, subjects
who received NAL ER will continue on NAL ER and subjects who received placebo will crossover
to NAL ER.
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- Individuals diagnosed with generalized nodular PN, covering 2 separate body parts, and
10 or more pruriginous nodules
- Severe itch due to PN
- Age 18 years and older at the time of consent, and a life expectancy of at least 18
months.
- Individuals using antidepressants must be on a stable dose for a minimum of 4 weeks
prior to screening.
Exclusion Criteria:
- Pruritus due to localized PN (only one body part affected), or less than 10 nodules
- Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic
dermatitis or bullous pemphigoid for example).
- Unresolved acute secondary dermatoses active (unresolved) in the last (a) 4 weeks:
localized contact dermatitis, environmental exposures, superficial burns, or viral
exanthems; (b) 8 weeks: skin or environmental infestations, such as scabies, lice, or
bed bugs.
- Other non-dermatologic diseases that could be a potential cause of concomitant
pruritus (e.g., thyroid disease, celiac disease, hepatitis C virus [HCV]) must either
have resolved, been successfully treated (i.e., HCV RNA negative) or must be
successfully managed with stable, optimized treatment (e.g., thyroid replacement,
dietary management with resolution of symptoms, respectively) for at least 3 months
prior to screening
- History of a major psychiatric disorder such as bipolar disorder or schizophrenia.
History of active substance abuse in the last 3 years.
- Known intolerance (GI, CNS symptoms) or hypersensitivity/drug allergy to opioids.
- Use of certain concomitant medications and treatments within a period prior to the
study, or requirement for these medications during the study:
- Potential subjects taking opiates, gabapentin, pregabalin, calcineurin
inhibitors, cannabinoid agonists, capsaicin, cryosurgery, topical doxepin,
thalidomide or methotrexate, topical antihistamines or topical corticosteroids
require a 14-day washout.
- Within 4 weeks prior to screening: ultraviolet (UV)-therapy, exposure to any
investigational medication, including placebo
- Within 3 months prior to screening: Non-insulin biologics (including monoclonal
antibodies) that modify the immune system,
- Individuals taking monoamine oxidase inhibitors are excluded, as concomitant
opiate use may increase the risk for serotonin syndrome.
- Myocardial infarction or acute coronary syndrome within the previous 3 months, as
reported by the subject.
- Individuals with prolonged QTcF
Individuals with HIV can be included if they meet the following criteria: (a) currently on
a stable (> 6 months stable use) and well tolerated highly active antiretroviral therapy
regimen; (b) CD4 count > 500 cells/mL; and (c) HIV ribonucleic acid (RNA) < 50 copies/mL
documented for at least 6 months prior to enrollment.