EUCTR2017-002581-51-DE
Active, not recruiting
Phase 1
An Open-Label, Pilot Study to Assess the Efficacy and Safety Of AK002 (Siglec-8) in Patients with Antihistamine-Resistant Chronic Urticaria - CURSIG
ConditionsPatients with different types of chronic urticaria resistant to standard dose antihistaminesMedDRA version: 20.0Level: PTClassification code 10052568Term: Urticaria chronicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with different types of chronic urticaria resistant to standard dose antihistamines
- Sponsor
- Allakos Inc.
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adults (\= 18 and \= 85 years old)
- •2\) Body weight \<125 Kg
- •3\) Informed consent signed and dated
- •4\) Able to read, understand, and willing to sign the informed consent form and comply with study procedures
- •5\) Diagnosis of CU for at least 3 months, refractory to antihistamine treatment in single or 4\-fold dosage
- •6\) Willing, committed, and able to return for all clinic visits and complete all study\-related procedures, including willingness to have IV infusion of study drug administered by a qualified person
- •7\) Females of childbearing potential must have a negative pregnancy test at Baseline. Female subjects must be willing to use highly effective contraception (Pearl\- 4 Index \<1\) or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. A woman will be considered not of childbearing potential if she is post\-menopausal for greater than two years (FSH \>40 mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- •Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- •8\) No participation in other clinical trials 4 weeks before participation in this study
- •9\) Uncontrolled CU (UCT \<12\) at the time of enrollment
Exclusion Criteria
- •1\) Acute urticaria
- •2\) Concurrent/ongoing treatment with immunosuppressives (e.g.,
- •cyclosporine, methotrexate, dapsone, or others) within 4 weeks or
- •5 half\-lives prior to Baseline, whichever is longer
- •3\) Significant medical condition rendering the patient
- •immunocompromised or not suitable for a clinical trial
- •4\) Significant concomitant illness that would adversely affect the
- •subject’s participation or evaluation in this study
- •5\) History of malignancies within five years prior to screening other
- •than a successfully treated non\-metastatic cutaneous, basal, or
Outcomes
Primary Outcomes
Not specified
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