Phase 2
N=47
A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
Chronic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT03436797 ↗Enrolled (actual)
47
Serious AEs
9.6%
Results posted
Jan 2024
Primary outcome: Primary: Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase — 6.5; 3.4; 11.1; 4.8 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AK002 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allakos Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase |
6.5; 3.4; 11.1; 4.8 | — |
Summary
This is a Phase 2a, open-label study to assess the effects of AK002
Eligibility Criteria
Inclusion Criteria
- Adults (≥ 18 and ≤ 85 years old)
- Body weight 40mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- No participation in other clinical trials 4 weeks before participation in this study
- Uncontrolled CU (UCT 500ml of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of drug
- Known hypersensitivity to any ingredients of AK002 or drugs related to AK002 (e.g., monoclonal antibodies, polyclonal gamma globulin)
Data sourced from ClinicalTrials.gov (NCT03436797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.