A Phase 1 interventional study of AK006 IV in Chronic Spontaneous Urticaria, sponsored by Allakos Inc.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Allakos Inc. · Phase 1, Interventional, and Treatment
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's enrollment of 29 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Allakos Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks.
Drug: AK006 IV
Formulation for intravenous infusion
Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
Time frame: Through study completion, approximately 30 weeks
Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs
Time frame: Through study completion, approximately 30 weeks
AK006 serum concentrations
Time frame: Through study completion, approximately 30 weeks
AK006 Anti-drug Antibodies (ADAs)
Number of participants with positive or negative AK006-ADAs.
Time frame: Through study completion, approximately 30 weeks
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Allakos Inc.