Evaluating the safety and effects of BGB-45035 in healthy adults and those with autoimmune skin diseases

Phase 1a/1b Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and Its Safety and Tolerability in Patients With Autoimmune Dermatological Diseases

This study is testing a new drug called BGB-45035 to see if it's safe and effective for healthy adults and those with autoimmune skin diseases like atopic dermatitis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 211 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: BeOne Medicines (Industry-sponsored)
• Locations: 13 sites (Waitara, New South Wales and 12 other locations)
• Trial ID: NCT06342713 on ClinicalTrials.gov

What this trial studies

This study is the first-in-human evaluation of BGB-45035, focusing on its safety, tolerability, pharmacokinetics, and pharmacodynamics. It involves administering both single and multiple ascending doses to healthy participants, followed by a phase assessing its effects on adults with autoimmune dermatological diseases such as atopic dermatitis and prurigo nodularis. The study will last up to 24 months, with treatment durations varying from 14 days to 12 weeks, depending on the phase. A biomarker cohort will also be included to further evaluate the drug's effects.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 55 years and adults with autoimmune dermatological diseases.

Not a fit: Patients with conditions outside the specified autoimmune dermatological diseases or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients with autoimmune dermatological diseases.

How similar studies have performed: Other studies evaluating similar pharmacological approaches have shown promise, but this specific drug and its effects are novel.

Eligibility criteria

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.

Where this trial is running

Waitara, New South Wales and 12 other locations

• Innovate Clinical Research — Waitara, New South Wales, Australia (Recruiting)
• Cmax Clinical Research — Adelaide, South Australia, Australia (Active_not_recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Completed)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Active_not_recruiting)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Completed)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Completed)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Completed)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Completed)
• The Affiliated Hospital of Qingdao University Branch West Coast — Qingdao, Shandong, China (Active_not_recruiting)
• Chengdu Second Peoples Hospital — Chengdu, Sichuan, China (Completed)
• Optimal Clinical Trials Ltd — Auckland, New Zealand (Recruiting)
• Pacific Clinical Research Network Auckland — Takapuna, New Zealand (Recruiting)
• Lakeland Clinical Trials Wellington — Upper Hutt, New Zealand (Recruiting)

Study contacts

• Study coordinator: BeiGene

Conditions Healthy Participants; Healthy Subjects; Healthy Volunteers; Autoimmune Diseases; Healthy Adult Participants; Atopic Dermatitis; Prurigo Nodularis; BGB-45035