Peanut allergy MedDRA version: 20.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: AK002
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: none
Current Sponsor code: AK002
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Allakos, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Able to provide written informed consent 2) Male or female aged =18 and =80 years at the time of signing the ICF 3) Clinical history of allergy to peanuts or peanut-containing foods, with serum IgE antibodies to Ara h2 of =2 kUA/L (determined by the UniCAP™ automated immunoassay system) and peanut skin prick test wheal diameter =3 mm larger compared with control (calculated per Section 10.5.3)) 4) Experiences dose-limiting allergic symptoms at or before reaching the 300 mg single dose of peanut protein (443 mg cumulative) during the baseline food challenge (Food Challenge 1) 5) Willing and able to comply with the study procedures and visit schedule 6) Female patients must be either post-menopausal for at least 1 year at Screening 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 from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to any constituent of the study 2) Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study 3) Presence of abnormal laboratory values considered to be clinically significant by the Investigator 4) Any disease or condition (medical or surgical) which, in the opinion of the Investigator, would place the patient at increased risk 5) History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension 6) History of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers 7) Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (or 90 days or 5 half-lives, whichever is longer, for biologic products) 8) Treatment with chemotherapy or radiotherapy in the preceding 6 months 9) Treatment for a clinically significant helminthic parasitic infection within 6 months of screening 10) Use during the 30 days before Screening (or 5 half-lives, whichever is longer) or use during the Screening Period of systemic corticosteroids 11) Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment, during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of study drug administration 12) Known history of alcohol, drug, or other substance abuse or dependence 13) Any other reason that (in the opinion of the Investigator or Medical Monitor) makes the patient unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To evaluate the safety and tolerability of AK002 in adult patients with peanut allergy. 2) To evaluate preliminary efficacy of AK002 in patients with peanut allergy as measured by the proportion of responders (defined as a 2-step increase from baseline in antigen threshold) and the change from baseline in maximum peanut protein dose achieved.;Secondary Objective: 1) To evaluate the pharmacodynamics of AK002 in patients with peanut allergy as measured by changes from baseline in absolute blood counts of eosinophils and basophils.;Primary end point(s): Safety endpoints • Physical examination • Vital signs • 12-lead ECGs • Hematology • Blood chemistries • Urinalysis • Anti-drug antibodies • Adverse events Pharmacokinetic Endpoints Serum concentrations of AK002 as measured by a validated enzyme-linked immunosorbent assay (ELISA) from samples collected prior to dosing on dosing days (1, 29, and 57 [if applicable]) and at Food Challenge 4 (Day 71 or Day 115, as applicable). AK002 concentrations in serum will be used to calculate AK002 exposure. Pharmacodynamic/Efficacy Endpoints • Proportion of patients who respond to treatment, defined as a 2-step increase from baseline in antigen threshold. • Changes from baseline in the maximum peanut protein dose. • Changes from baseline in total eosinophil and basophil counts.;Timepoint(s) of evaluation of this end point: Throughout the whole study period from screeening visit on day -33 to - 77 until end of follow-up period up to day 122. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Denmark
Contacts
Public ContactOdense Research Cent f Anaphylaxis
Odense University Hospital
Outcome results
None listed