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NCT06072157 (AK006 in Chronic Spontaneous Urticaria): BVCT ex-ante prediction vs. reported outcome

On 3 Nov 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 27 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06072157
Drug Name
AK006
Drug MoA
anti-SIGLEC6 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Chronic Spontaneous Urticaria
Human Patients
136
Sponsor
Allakos
Phase
Phase 1

Prediction of , index 1813

Prospective Prediction
Prediction Index
1813
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in UAS7/ISS7 inferior to barzolvolimab)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in UAS7/ISS7 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
85 days in advance
Readout Data Interpretation
AK006 failed to demonstrate therapeutic efficacy and further developments discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AK006 in Healthy Subjects and in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria
Phase
Phase 1
Status
Completed
Enrollment
136
Lead sponsor
Allakos Inc.
Conditions
Healthy Participants; Chronic Spontaneous Urticaria
Interventions
DRUG: AK006-IV; DRUG: Placebo-IV; DRUG: AK006-SC; DRUG: Placebo-SC
Design
Randomized · Sequential · Double
Primary purpose
Treatment
Start
2023-08-28
Primary completion
2025-05-12
Completion
2025-05-12
Primary outcomes
  • Incidence and severity of adverse events (AEs) (Screening to Day 113 (Part A and D), Screening to Day 141 (Part B), and Screening to Day 197 (Part C))
  • Incidence of AEs of special interest (Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C))
  • AEs leading to discontinuation (Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C))
  • Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs (Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C))

NCT06072157 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials