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New drug targets mysterious chronic itch

NCT ID NCT07074977

Symptom relief Sponsor: Galderma R&D Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This Phase 2 study tests a drug called nemolizumab in 50 adults with chronic itching that has no known cause. The goal is to see how the drug works in the body and whether it can reduce itching over 16 weeks. Participants receive either nemolizumab or a placebo injection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nemolizumab
What this could lead to
If successful, this could point toward a new treatment option for people with chronic itching that has no clear cause.
What could go wrong
This is an early Phase 2 study with only 50 participants, so results may not apply to everyone. The drug may not reduce itching significantly, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be 18 years of age or older. 2. Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit. 3. Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline. 4. 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. 5. History of insufficient control of the chronic pruritus with prior treatment. 6. Peak Pruritus Numeric Rating Scale (PP NRS) score greater than and equal to (\>=) 7 in the 24-hour period prior to the Screening visit. 7. 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. 8. 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 participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 9. 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 and procedural requirements of the clinical study protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply : Medical Conditions 1. 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. 2. Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization. 3. 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. 4. 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 with psychological disorders such as delusional parasitosis or Morgellons disease). 5. Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk. 6. History of bullous pemphigoid or positive bullous pemphigoid autoantibodies at screening. 7. History of mastocytosis or serum total tryptase greater than (\>) 20 nanograms per milliliter (ng/ml) at screening. 8. Active tuberculosis (TB) or non-tuberculosis mycobacterial infection, or a history of incompletely treated TB. 9. 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 \[PCR\]), or Human Immunodeficiency Virus \[HIV\] antibody) at the screening visit. 10. Known or suspected immunodeficiency. 11. Lymphoproliferative disease or malignancy within the last 5 years. 12. 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 nemolizumab's safety or efficacy or interfere with the participant's ability to comply with protocol mandated activities. 13. Receipt of prohibited medications within the specified timeframe before the baseline visit 14. Previous participation in a clinical study with nemolizumab 15. 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 is in an exclusion period (if verifiable) from a previous study. 16. Body weight \< 30 kg. 17. Prior treatment with commercially available nemolizmab 18. Hypersensitivity to the active substance (nemolizumab) or to any of the excipients of the study intervention. 19. Requiring rescue therapy for pruritus during the screening period. 20. Alcohol or substance abuse within 6 months of the screening visit. 21. Planned or anticipated major surgical procedure or other activity that would interfere with the participant's ability to comply with protocol-mandated assessments. 22. Pregnant or breastfeeding female, or female planning a pregnancy during the study. 23. 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 contain all considerations relevant to a patient's potential participation in a clinical trial.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pruritus of unknown origin

Contacts and locations

Locations

  • Galderma Investigational (Site # 7131)

    Spartanburg, South Carolina, 29307, United States

  • Galderma Investigational (Site# 7048)

    Baltimore, Maryland, 21201, United States

  • Galderma Investigational Site (#7129)

    Bowling Green, Kentucky, 42104, United States

  • Galderma Investigational Site (#7130)

    The Bronx, New York, 10455, United States

  • Galderma Investigational Site (#8212)

    Portand, Oregon, 97210, United States

  • Galderma Investigational Site (#8255)

    Philadelphia, Pennsylvania, 19103, United States

  • Galderma Investigational Site (#8295)

    Miami, Florida, 33136, United States

  • Galderma Investigational Site (#8768)

    Tucson, Arizona, 85718, United States

  • Galderma Investigational Site (#9975)

    Sacramento, California, 95815, United States

  • Galderma Investigational Site (site# 7054)

    Tampa, Florida, 33609, United States

  • Galderma Investigational Site (site# 7075)

    San Francisco, California, 94115, United States

  • Galderma Investigational Site (site# 7110)

    New City, New York, 10956, United States

  • Galderma Investigational Site (site# 7111)

    Fargo, North Dakota, 58103, United States

  • Galderma Investigational Site (site# 8003)

    Webster, Texas, 77598, United States

  • Galderma Investigational Site (site# 8021)

    San Diego, California, 92123, United States

  • Galderma Investigational Site (site# 8045)

    Québec, Quebec, G1V 4X7, Canada

  • Galderma Investigational Site (site# 8108)

    Las Vegas, Nevada, 89145, United States

  • Galderma Investigational Site (site# 8130)

    Los Angeles, California, 90045, United States

  • Galderma Investigational Site (site# 8142)

    Indianapolis, Indiana, 46250, United States

  • Galderma Investigational Site (site# 8521)

    Saint Joseph, Missouri, 64506, United States

  • Galderma Investigational Site (site# 8608)

    Santa Monica, California, 90404, United States

  • Galderma Investigational Site (site# 8636)

    Fountain Valley, California, 92708, United States

  • Galderma Investigational Site (site# 8725)

    Morgantown, West Virginia, 26505, United States

  • Galderma Investigational Site (site# 8743)

    Ann Arbor, Michigan, 48109, United States

  • Galderma Investigational Site (site# 8862)

    Fairfax, Virginia, 22031, United States

  • Galderma Investigational Site (site# 8893)

    Birmingham, Alabama, 35244, United States

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