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New treatment option for Chronic Pruritus of Unknown Origin
Official title Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
ClinicalTrials.gov ID: NCT07074977
What this study is testing
What is nemolizumab?
nemolizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic pruritus of unknown origin.
Also referred to as CD14152.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must be 18 years of age or older.
- Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit.
- Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator...
- The pruritus must affect at least 4 of the following body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior...
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply : Medical Conditions
- Known dermatologic, systemic, neurologic or psychiatric condition(s), other than dry skin, that considered by the investigator to be the primary...
- Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals...
- Diagnosis of chronic pruritus of neuropathic origin including but not limited to scalp dysesthesia, brachioradial pruritus, generalized neuropathic...
- Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk.
See the full eligibility criteria
Who can join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must be 18 years of age or older.
- Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit.
- Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline.
- The pruritus must affect at least 4 of the following body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior trunk, posterior trunk.
- History of insufficient control of the chronic pruritus with prior treatment.
- Peak Pruritus Numeric Rating Scale (PP NRS) score greater than and equal to (\>=) 7 in the 24-hour period prior to the Screening visit.
- Weekly average Peak Pruritus Numeric Rating Scale (PP NRS) score \>= 7 in the week (7 days) immediately prior to randomization, as recorded in the patient diary.
- Female of childbearing potential must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study intervention injection. Contraceptive use by...
- Females of non-childbearing potential must meet 1 of the following criteria:
- Absence of menstrual bleeding for 1 year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range
- Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before screening 10. Signed informed consent. 11. Participant is willing and able to comply with all of the time commitments...
What rules you out
- Participants are excluded from the study if any of the following criteria apply : Medical Conditions
- Known dermatologic, systemic, neurologic or psychiatric condition(s), other than dry skin, that considered by the investigator to be the primary cause of current pruritus.
- Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
- Diagnosis of chronic pruritus of neuropathic origin including but not limited to scalp dysesthesia, brachioradial pruritus, generalized neuropathic pruritus or chronic pruritus of psychogenic origin (pruritus associated...
- Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk.
- History of bullous pemphigoid or positive bullous pemphigoid autoantibodies at screening.
- History of mastocytosis or serum total tryptase greater than (\>) 20 nanograms per milliliter (ng/ml) at screening.
- Active tuberculosis (TB) or non-tuberculosis mycobacterial infection, or a history of incompletely treated TB.
- Positive serology results Hepatitis B surface antigen or (HBsAg) or Antibody to Hepatitis B core antigen (HBcAb), Hepatitis C virus (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction...
- Known or suspected immunodeficiency.
- Lymphoproliferative disease or malignancy within the last 5 years.
- Presence of major psychiatric diagnosis, clinically significant dementia, intellectual impairment, or any medical condition or disability which, in the investigator's opinion, may confound the assessment of...
- Receipt of prohibited medications within the specified timeframe before the baseline visit
- Previous participation in a clinical study with nemolizumab
- Currently participating or participated in any other study of an investigational drug or device, within the past 8 weeks (or 5 half-lives of the investigational drug, whichever is longer) before the screening visit, or...
- Body weight \< 30 kg.
- Prior treatment with commercially available nemolizmab
- Hypersensitivity to the active substance (nemolizumab) or to any of the excipients of the study intervention.
- Requiring rescue therapy for pruritus during the screening period.
- Alcohol or substance abuse within 6 months of the screening visit.
- Planned or anticipated major surgical procedure or other activity that would interfere with the participant's ability to comply with protocol-mandated assessments.
- Pregnant or breastfeeding female, or female planning a pregnancy during the study.
- Vulnerable participant as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP). The above information is not intended to...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Bowling Green, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Saint Joseph, Missouri, United States
- Las Vegas, Nevada, United States
- New City, New York, United States
- The Bronx, New York, United States
- Fargo, North Dakota, United States
- Portland, Oregon, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Fountain Valley, California, United States; Los Angeles, California, United States; Sacramento, California, United States; San Diego, California, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.