NCT07005713 is a Phase 1 clinical trial of BGB-16673 in Chronic Spontaneous Urticaria, sponsored by BeiGene.

Who is sponsoring NCT07005713?

NCT07005713 is sponsored by BeiGene.

What drugs are being tested in NCT07005713?

Interventions in NCT07005713: BGB-16673, Placebo.

What condition does NCT07005713 study?

NCT07005713 studies Chronic Spontaneous Urticaria.

Is NCT07005713 still recruiting?

NCT07005713 is currently active, enrolled. Last updated 3 February 2026.

Last reviewed 2026-02-03 · How we verify

NCT07005713

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria

Active, enrolled Phase 1 Last updated 3 February 2026

What this trial tests

Phase 1 trial testing BGB-16673 in Chronic Spontaneous Urticaria in 34 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 July 2025

Primary endpoint
17 April 2026

17 April 2026

Quick facts

Lead sponsor	BeiGene
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	34
Start date	19 July 2025
Primary completion	17 April 2026
Estimated completion	17 April 2026
Sites	8 locations across China

Drugs / interventions tested

BGB-16673 — full drug profile →
Placebo

Conditions studied

Chronic Spontaneous Urticaria — all drugs for Chronic Spontaneous Urticaria →

Sponsor

BeiGene — full company profile →

Who can join

Adults 18 to 70, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a Phase 1b, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of multiple-ascending doses of BGB-16673 in adults with chronic spontaneous urticaria (CSU).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401
Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond.
Hsu FI, Bernstein JA, Chhiba KD, Saini SS. · · 2026 · cited 1× · PMID 41654334 · DOI 10.1016/j.jaip.2025.11.038
Emerging IgE and non-IgE targeted therapies for chronic urticaria.
Chhiba KD, Saini SS. · · 2026 · cited 1× · PMID 41270830 · DOI 10.1016/j.anai.2025.11.008

Verify or expand the search:

Other trials of BGB-16673

Trials testing the same drug.

NCT07508995 — A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Pat · Phase 2 · not yet recruiting
NCT06973187 — A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Ch · Phase 3 · recruiting
NCT06970743 — A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leuk · Phase 3 · recruiting
NCT06846671 — A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lympho · Phase 3 · recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed

Other recruiting trials for Chronic Spontaneous Urticaria

Currently open trials in the same condition.

NCT07316114 — A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spont · recruiting
NCT07358364 — Remibrutinib in Real-world Clinical Practice · recruiting
NCT07358780 — Remibrutinib in Real-world Clinical Practice - a US Sub-study · recruiting
NCT07408219 — A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients · recruiting
NCT07219615 — A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. · Phase 2 · recruiting

Other BeiGene trials

Trials by the same sponsor.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting
NCT06776679 — A Study of How [14C]-BGB-16673 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy P · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07005713 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 3 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07005713.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing