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New drug BGB-45035 tested for eczema and itchy skin condition

NCT ID NCT06342713

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new drug called BGB-45035 for the first time in humans. It looked at safety in healthy volunteers and then in people with autoimmune skin diseases like atopic dermatitis (eczema) and prurigo nodularis (a condition causing intensely itchy bumps). The goal was to find safe doses and see how the body processes the drug.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

203 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2026

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 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for Parts A-D and Part F: 1. Female or male participants between the ages of 18 and 55 years inclusive (ages 18 and 45 years for Part C). 2. BMI of 18 to 32 kg/m\^2; and a total body weight \> 50 kg (110 lbs). 3. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. 4. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 5. Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 90 days after the last dose of study drug. 6. Female participants of childbearing potential can only join Part F and must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 90 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug. Inclusion Criteria for Part E 1. Female or male participants between the ages of 18 to 75 years of age. 2. Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 90 days after the last dose of study drug. They must also have a negative urine pregnancy test at baseline before first dose of study drug. 3. AD Cohort E1: 1. Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that has been present for at least 1 year before the Screening Visit. 2. Prior to baseline assessment, participants with AD must have used only nonmedicated topical emollients twice daily for at least 7 days, without any active ingredients or additives that could impact AD treatment (such as hyaluronic acid, urea, ceramide, or filaggrin degradation products). Participant's response to treatment must have remained inadequate at baseline. Additionally, the participant must be willing and able to adhere to standardized background topical therapy as outlined in the protocol throughout the remainder of the study. 4. PN Cohort E2: 1. Diagnosed as PN by a dermatologist for at least 3 months before the Screening Visit with prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs. 2. Minimum of 20 PN lesions in total on either of the following: both legs, both arms, and/or the trunk at the Screening Visit and on Day 1. General Inclusion Criteria: 1\. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study. Exclusion Criteria: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). 2. Any condition possibly affecting drug absorption (eg, gastrectomy or cholecystectomy). 3. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer. 4. 12-lead ECG demonstrating QTcF \> 450 milliseconds. 5. Clinically significant abnormality on chest radiograph performed at screening or within 3 months of screening date. 6. History of tuberculosis or active or latent or inadequately treated infection, positive IGRA tests 7. Herbal supplements (including St. John's Wort) and hormone replacement therapy must be discontinued 14 days prior to the first dose of study medication. 8. Vaccination with live virus, attenuated live virus, or any live viral components within the 6 weeks prior to the first dose of study drug or is to receive these vaccines at any time during treatment or within 8 weeks following completion of study treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Chengdu Second Peoples Hospital

    Chengdu, Sichuan, 610021, China

  • Cmax Clinical Research

    Adelaide, South Australia, SA 5000, Australia

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, China

  • Innovate Clinical Research

    Waitara, New South Wales, NSW 2077, Australia

  • Lakeland Clinical Trials Wellington

    Upper Hutt, 5018, New Zealand

  • Optimal Clinical Trials Ltd

    Auckland, 1010, New Zealand

  • Pacific Clinical Research Network Auckland

    Takapuna, 0622, New Zealand

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215002, China

  • The Affiliated Hospital of Qingdao University Branch West Coast

    Qingdao, Shandong, 266555, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

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