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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 April 2023 |
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Main ID: |
NCT03664960 |
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Date of registration:
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06/09/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
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Scientific title:
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A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) |
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Date of first enrolment:
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November 14, 2018 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03664960 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Craig Paterson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allakos Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Provide written informed consent.
2. Completed Study AK002-003, defined as having received 4 infusions of study drug and
followed through Day 113 (±3 days) in Study AK002-003 and willing to begin extended
dosing on or about Day 113.
3. Able and willing to comply with all study procedures.
4. Female patients must be either post-menopausal for at least 1 year or surgically
sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3
months, or if of childbearing potential, have a negative pregnancy test and agree to
use dual methods of contraception, or abstain from sexual activity until the end of
the study, or for 120 days following the last dose of study drug, whichever is longer.
5. Male patients with female partners of childbearing potential must agree to use a
highly effective method of contraception 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 at any time
during study participation.
Exclusion Criteria:
1. Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
2. Known hypersensitivity to any constituent of the study drug.
3. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the
opinion of the Investigator, would place the patient at increased risk.
4. Planned or expected vaccination with live attenuated vaccines during the treatment, or
vaccination expected within 5 half-lives (4 months) of AK002 administration.
5. Women who are pregnant, breastfeeding, or planning to become pregnant while
participating in the study.
6. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes
the patient unsuitable for enrollment.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophilic Gastroenteritis
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Eosinophilic Duodenitis
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Eosinophilic Gastritis
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Intervention(s)
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Drug: AK002
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Primary Outcome(s)
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Changes in the number of eosinophils in gastric and/or duodenal mucosa
[Time Frame: Baseline to Day 729]
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The safety and tolerability of AK002 as assessed by symptom-directed physical examination of reported or observed patient symptoms warranting examination, including assessments of possible infusion site reactions and infusion-related reactions
[Time Frame: Day 1 to Day 785 (End of Study)]
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Evaluation of symptoms of EG and/or EoD (formerly referred to as EGE) using a daily disease-specific patient questionnaire (PRO Questionnaire)
[Time Frame: Baseline to Day 785 (End of Study)]
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The safety and tolerability of AK002 by evaluating adverse events assessed using the CTCAE version 4.03
[Time Frame: Day 785 (End of Study)]
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Secondary ID(s)
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AK002-003X
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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