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Trial record 1 of 1 for:    AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
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A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria (CURSIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436797
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Allakos, Inc.

Brief Summary:
This is a Phase 2a, open-label, study to assess the effects of AK002, given as monthly intravenous infusions at up to 3 mg/kg. A total of 47 patients will be enrolled across 2-4 sites. All patients enrolled in the study will receive 6 monthly infusions of AK002 and will then be followed for another 8 weeks. Some patients will have the option to receive an additional 12 months of extended dosing.

Condition or disease Intervention/treatment Phase
Chronic Urticaria Drug: AK002 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Pilot Study to Assess the Efficacy and Safety of AK002 (Siglec-8) in Subjects With Antihistamine-Resistant Chronic Urticaria
Actual Study Start Date : January 23, 2018
Actual Primary Completion Date : November 21, 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: AK002
    AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).


Primary Outcome Measures :
  1. change in Urticaria Control Test (UCT), a score for symptom control in chronic urticaria, in CU subjects after treatment with AK002. [ Time Frame: Day 1 (baseline) to Week 22 ]

Secondary Outcome Measures :
  1. Change in disease activity as assessed by UAS7 [ Time Frame: From Day 1 to day 29, 85, 155, and 197 ]
  2. Change in disease activity as assessed by CholUAS7 [ Time Frame: From Day 1 to day 29, 85, 155, and 197 ]
  3. Change in number of symptom-free days per week (patient diary based CSU score) [ Time Frame: From Day 1 to day 29, 85, 155, and 197 ]
  4. Change in quality-of-life scores assessed by AE-QoL [ Time Frame: From Day 1 to day 29, 85, 155, and 197 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 three 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). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years (FSH >40mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
  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 squamous cell carcinoma and/or in situ cancer
  6. Presence of clinically significant laboratory abnormalities
  7. Lactating women or pregnant women
  8. Substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures
  9. Subjects who are detained officially or legally to an official institute or those that have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities will be excluded from the study
  10. Use of omalizumab within the last 3 months
  11. Receipt of intravenous IgG therapy 30 days prior to Baseline
  12. Plasmapheresis 30 days prior to Baseline
  13. Use (daily or every other day) of Doxepin 14 days prior to Baseline
  14. Receipt of inactive vaccination or live attenuated vaccine 30 days prior to Baseline
  15. Use of H2 antihistamines 7 days before Baseline
  16. Intake of leukotriene antagonists within 7 days prior to enrollment
  17. Intake of systemic corticosteroids (e.g., oral or depot) within 14 days prior to enrollment
  18. Positive screening for ova and parasite test at Baseline
  19. Treatment of helminthic parasite within 6 months of screening
  20. Positive HIV serology at screening
  21. Positive Hepatitis serology at baseline, except for vaccinated patients or patients with past but resolved hepatitis at screening
  22. Donation or loss of >500ml of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of drug
  23. Known hypersensitivity to any ingredients of AK002 or drugs related to AK002 (e.g., monoclonal antibodies, polyclonal gamma globulin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436797


Locations
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United States, Florida
Riverside Clinical Research
Edgewater, Florida, United States, 32132
United States, Ohio
Bernstein Clinical Research Center
Cincinnati, Ohio, United States, 45231
Germany
Charite University Medicine
Berlin, Germany, 10117
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Allakos, Inc.
Investigators
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Study Director: Henrik Rasmussen, MD, PhD Allakos, Inc.

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Responsible Party: Allakos, Inc.
ClinicalTrials.gov Identifier: NCT03436797    
Other Study ID Numbers: AK002-006
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs