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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06342713




Registration number
NCT06342713
Ethics application status
Date submitted
26/03/2024
Date registered
2/04/2024

Titles & IDs
Public title
A 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 in Adults With Autoimmune Dermatological Diseases
Scientific title
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
Secondary ID [1] 0 0
CTR20243170
Secondary ID [2] 0 0
BGB-45035-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Participants 0 0
Healthy Subjects 0 0
Healthy Volunteers 0 0
Autoimmune Diseases 0 0
Healthy Adult Participants 0 0
Atopic Dermatitis 0 0
Prurigo Nodularis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-45035
Treatment: Drugs - Placebo

Experimental: Phase 1a Part A (Single Ascending Dose) - Phase 1a Part A is designed to assess the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic profile of BGB-45035 following single-ascending doses (SAD) in healthy participants.

Experimental: Phase 1a Part B (Multiple Ascending Dose) - Phase 1a Part B is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy participants.

Experimental: Phase 1a Part C (Chinese Substudy) - Phase 1a Part C is designed to assess safety, tolerability, PK, and pharmacodynamic profile after repeated dosing of BGB-45035 in healthy Chinese participants.

Experimental: Phase 1a Part D (Food Effect) - Phase 1a Part D is designed to assess the effect of food on BGB-45035 exposure.

Experimental: Phase 1b Part E (AD Cohort E1) - Phase 1b AD Cohort E1 is designed to assess the safety, tolerability, and efficacy of a selected dose of BGB-45035 in participants with moderate to severe AD.

Experimental: Phase 1b Part E (PN Cohort E2) - Phase 1b PN Cohort E2 is designed to assess the safety, tolerability, and efficacy of a targeted dose of BGB-45035 in participants with moderate to severe PN.


Treatment: Drugs: BGB-45035
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
From the first dose of study drug to 30 days after the last dose; up to approximately 44 days for Phase 1a and up to 16 weeks for Phase 1b
Primary outcome [2] 0 0
Phase 1a Parts A-D: Number of participants with clinically significant changes from baseline in clinical laboratory values
Timepoint [2] 0 0
Baseline and up to approximately 1 month
Primary outcome [3] 0 0
Phase 1a Parts A-D: Number of participants with clinically significant changes from baseline in vital signs
Timepoint [3] 0 0
Baseline and up to approximately 1 month
Primary outcome [4] 0 0
Phase 1a Parts A-D: Number of participants with clinically significant changes from baseline in cardiac conduction intervals
Timepoint [4] 0 0
Baseline and up to approximately 1 month
Secondary outcome [1] 0 0
Phase 1a Parts A & D: Area under the plasma concentration time curve from time zero to last quantifiable time (AUClast) of BGB-45035
Timepoint [1] 0 0
Up to approximately 14 days
Secondary outcome [2] 0 0
Phase 1a Parts A & D: Area under the plasma concentration time curve from time zero to infinite time (AUCinf) of BGB-45035
Timepoint [2] 0 0
Up to approximately 14 days
Secondary outcome [3] 0 0
Phase 1a Parts B & C: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) of BGB-45035
Timepoint [3] 0 0
Up to approximately 14 days
Secondary outcome [4] 0 0
Phase 1a Parts A, B, C & D: Maximum observed plasma concentration (Cmax) of BGB-45035
Timepoint [4] 0 0
Up to approximately 14 days
Secondary outcome [5] 0 0
Phase 1a Parts A, B, C & D: Time to maximum plasma concentration (Tmax) of BGB-45035
Timepoint [5] 0 0
Up to approximately 14 days
Secondary outcome [6] 0 0
Phase 1a Parts B & C: Trough plasma concentration (Ctrough) of BGB-45035
Timepoint [6] 0 0
Up to approximately 14 days
Secondary outcome [7] 0 0
Phase 1a Parts A, B, C & D: Half life (t½) of BGB-45035
Timepoint [7] 0 0
Up to approximately 14 days
Secondary outcome [8] 0 0
Phase 1a Parts A, B, & C: Apparent systemic clearance (CL/F) of BGB-45035
Timepoint [8] 0 0
Up to approximately 14 days
Secondary outcome [9] 0 0
Phase 1a Parts A, B, & C: Apparent volume of distribution (Vz/F) of BGB-45035
Timepoint [9] 0 0
Up to approximately 14 days
Secondary outcome [10] 0 0
Phase 1a Parts B & C: Accumulation Ratios of BGB-45035
Timepoint [10] 0 0
Up to approximately 14 days
Secondary outcome [11] 0 0
Phase 1b Part E (AD Cohort E1): Change from baseline in Eczema Area and Severity Index (EASI) score at all scheduled visits
Timepoint [11] 0 0
Baseline and up to 16 weeks
Secondary outcome [12] 0 0
Phase 1b Part E (AD Cohort E1): Change from baseline in Investigator Global Assessment (IGA) scale for Atopic Dermatitis (IGA-AD) score at all scheduled visits
Timepoint [12] 0 0
Baseline and up to 16 weeks
Secondary outcome [13] 0 0
Phase 1b Part E (PN Cohort E2): Change from baseline in Investigator Global Assessment (IGA) Stage score at all scheduled visits
Timepoint [13] 0 0
Baseline and up to 16 weeks
Secondary outcome [14] 0 0
Phase 1b Part E (PN Cohort E2): Change from baseline in Investigator Global Assessment (IGA) Activity score at all scheduled visits
Timepoint [14] 0 0
Baseline and up to 16 weeks
Secondary outcome [15] 0 0
Phase 1b Part E: Change from baseline of Peak Pruritus Numerical Rating Scale (PP-NRS) at all scheduled visits
Timepoint [15] 0 0
Baseline and up to 16 weeks
Secondary outcome [16] 0 0
Phase 1b Part E: Change from baseline in Average of Pruritus Numerical Rating Scale (AP-NRS) at all scheduled visits
Timepoint [16] 0 0
Baseline and up to 16 weeks

Eligibility
Key inclusion criteria
Phase 1a

1. Healthy female participants of non-childbearing potential and/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/m2; 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.

Phase 1b: Inclusion Criteria

1. Female or male participants between the ages of 18 to 75 years of age.
2. 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.
3. 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

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Cmax Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shandong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06342713