Tolerability and Potential Efficacy of AD17002 in Subjects With Allergic Rhinitis (NCT04088721) | Clinical Trial Compass
CompletedPhase 1/2
Tolerability and Potential Efficacy of AD17002 in Subjects With Allergic Rhinitis
Taiwan48 participantsStarted 2019-03-26
Plain-language summary
A single center, double-blind, randomized, dose-escalation study to assess the safety, tolerability and efficacy of 3 doses of AD17002 in comparison to placebo. Subjects will be randomized at 3:1 ratios in each of 3 cohorts to receive AD17002 or placebo.
Who can participate
Age range
20 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject 20-49 aged years, having a clinical history of allergic rhinitis (diagnosed by a physician) of 1 year duration or more and have received anti-allergy treatment during the previous year before the study enrollment.
. Subjects with HDM-specific IgE serum value ≥ 0.7 kUA/L during screening period.
. HDM allergic rhinitis symptoms during the baseline period defined as a total nasal symptoms score more than 6, at least on 5 of 7 consecutive calendar days in screening period. A subject receiving anti-allergy medication is required to washout of their medication before and during screening period of the trial until the required symptom threshold is met.
. No known prior clinical history of asthma.
. Subjects who are of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the trial. Acceptable methods of birth control are: intrauterine device, hormonal contraception, diaphragm with spermicide, contraceptive sponge, condom, vasectomy, as per local regulations or guidelines. Female subjects of childbearing potential must have negative serum pregnancy test at screening, and negative urine pregnancy test at randomization visit.
. A female subject who is not of reproductive potential and a male subject who is diagnosed to be sterile is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as: one who has either
. Reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea),
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerance of AD17002 treatments in patients with HDM allergy as measured by incidence of adverse events
. Six weeks postsurgical documented total hysterectomy and/or bilateral salpingo-oophorectomy, or
Exclusion criteria
. Has a clinically relevant, known history of symptomatic allergic rhinoconjunctivitis and/or asthma caused by mold, animal hair and dander, or other allergens (except HDM) to which the subject is regularly exposed and sensitized. Subjects without a known history of allergy other than to HDM, but show any positive result (on CAP test) towards the allergens could be accepted in the judgement of the investigator.
. Has any nasal condition that, in the judgement of the investigator, could confound the efficacy or safety assessments (e.g., nasal polyposis, nasal malformation, frequent nosebleeds, etc).
. Has a history of anaphylaxis reaction to any known or unknown cause.
. Has a history of chronic urticaria and/or angioedema within the last 2 years before Screening Visit.
. Immunosuppressed subjects as result of illness (e.g. HIV infection) or treatment.
. Has acute respiratory illness needing antibiotics or antivirals within 14 days prior to the Screening visit.
. Has acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to administration of first dose of study drug.
. Has any clinically relevant chronic disease (≥3 months duration) \[including but not limited to cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency, rheumatic arthritis, lupus and other autoimmune diseases\].