Are you suffering from Chronic Spontaneous Hives or Urticaria, and experiencing difficulty with daily activities?
Have you tried Antihistamines and they haven’t worked? We are looking for people with Chronic Spontaneous Urticaria (itch and hives) for a new research study.
About Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria (CSU) is an inflammatory skin disease that causes severe itching and wheals (hives).1,2
CSU is called “chronic” because symptoms occur over at least 6 weeks and up to several years. It is called “spontaneous” because it is difficult to predict when the symptoms will appear and there is no identifiable trigger.2,3
CSU can cause physical and emotional impacts such as embarrassing itching and scratching, skin lesions, loss of sleep due to irritation, work absences, irritability, depression and anxiety.3,4,6
CSU affects up to 3 million adults in the U.S. Initial treatment consists of over-the-counter non-sedating antihistamine medications; however, half of patients treated with non-sedating antihistamines still have CSU symptoms.2,3,5
What is the AK006-001 study?
Researchers at select research centers are looking for people 18 to 65 years old, with a diagnosis of Chronic Spontaneous Urticaria (CSU). The goal of the AK006-001 study is to learn more about the investigational medicine AK006, and whether and how it affects the symptoms of people suffering with CSU, and its associated safety risks and tolerability. AK006 is given as an IV infusion (intravenously) and is an investigational medicine, meaning that it hasn’t been fully tested and is not approved by any health authority, except for use in research studies like this one.
This is a Phase 1 clinical research study in which you may receive 4 consecutive IV infusions of the investigational medicine or a placebo every 4 weeks over a period of 12 weeks. There will be approximately 16 weeks of follow-up after the last dose. Qualified participants will receive study medication, lab tests and medical care related to the study at no cost. If you choose to participate you may receive compensation for your time and travel costs for study visits.
The study is a randomized study, meaning that participants are randomly assigned (like flipping a coin) to one of two groups. One group is given AK006-001 and the other group is given a placebo. A placebo looks like AK006 but contains no active ingredients. Participants have an 2:1 chance of being in either AK006 or placebo group. The study is double-blind so neither participants nor study doctors will know which group. Both groups are followed equally by the study doctor and research centers’ staff.
Who can participate in the AK006-001 study?
To pre-qualify for this study, you must*:
Be at least 18 to 65 years old
BMI between 20-32 kg/m2
Presence of hives and itch for >= 6 consecutive weeks at any time prior to screening
Have had a medical diagnosis of moderate to severe CSU for at least 6 months or more
Are currently on a stable dose of antihistamine
*Please note that other criteria will apply
What would participating in the study involve?
If you choose to participate there are a few different stages of the study.
The total study duration will be approximately 32 weeks. The study includes the following:
Screening Period
(4 weeks)
This is the time when the study doctor and staff determine if you are eligible for the study, and you decide if you want to participate. During this period, you will need to undergo some tests and procedures and you should be willing to start and maintain a stable dose of antihistamine (such as Bilaxten® (Bilastine), Zyrtec® (Cetirizine), Xyzal® (Levocetirizine), Allegra® (Fexofenadine), Claritin® and Alavert® (Loratadine), Clarinex® (Desloratadine), RupallTM (Rupatadine)(at screening and continue throughout the study if you are not already on an antihistamine.
Treatment Period
(12 weeks)
If you are eligible for the study, you will enter the Study Treatment Period which lasts for 12 weeks and requires 6 visits to the study site. Participants have a 2:1 chance of getting either the investigational medicine (AK006) or a placebo.
During the study treatment period you will visit the study site every 4 weeks to receive an IV infusion of the investigational medicine (AK006) or a placebo. During your visits to the study site, you will also have other tests performed such as blood and urine tests, and the study doctor and study team will monitor you closely.
Follow Up Period
(16 weeks)
There will be a follow-up period of 16 weeks after the last dose of investigational medicine or placebo, During the follow-up period, participants are required to visit the study site for 4 visits. During these visits, you will have some procedures like blood and urine tests and vital sign checks.
How do I Participate?
Complete the online questions to see if you pre-qualify
Submit your contact information
Answer our call to answer more questions and learn about the study
Confirm your interest and study site location
Speak with the study site about the next steps to participate
Frequently Asked Questions
Where can I find more information about this study?
What is a clinical research study?
Clinical studies explore whether a new medicine, or device is safe and effective for humans.
Clinical studies are scientific studies in which new medicines are tested to find out if they are safe and effective for people to take and use. They are one of the most important steps in bringing new potential medicines to patients.
Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new potential medicines to people with medical conditions. To bring new medicines to the public, they need be assessed in clinical studies, to determine the safety risks or side effects associated with them.
Clinical studies rely on the participation of volunteers. It can take several years for a new potential medicine to reach the public. Often, this timeline is due to how long it takes to complete the clinical study.
All approved prescription medicines have gone through clinical studies to make sure that they are effective and to understand what side effects may be involved.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centres, voluntary groups, or health care providers. The AK006-001 study is funded by a biotechnology company.
Every clinical study centre is led by a principal investigator, who is a medical doctor. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals.
What are the phases of clinical research studies?
Clinical studies are conducted in different phases.
Phase 1: After researchers have investigated the potential new medicine in laboratory tests or in animals to see if it has an effect and may potentially be safe to test in humans, the Phase 1 study is carried out to test the potential new medicine in a small group of people for the first time. This is done to evaluate its safety, determine a safe dosage range, and identify potential side effects. The potential new medicine is referred to as a study medicine since it is under investigation and not approved for use in normal clinical practice.
Phase 2: The study medicine is given to a larger group of people (compared to Phase 1) to see if it is effective and to further evaluate its safety.
Phase 3: The study medicine is given to large groups of people to confirm its efficacy, monitor side effects, compare it to commonly used treatments or placebo, and collect information that will allow the study medicine to be used safely.
What is a “placebo”?
“Placebo” is a term used to describe something that looks like the investigational medicine but does not contain any active ingredients.
References:
- Wertenteil S, Strunk A, Garg A. Prevalence estimates for chronic urticaria in the United States: A sex- and age-adjusted population analysis. J Am Acad Dermatol. 2019 Jul;81(1):152-156. doi: 10.1016/j.jaad.2019.02.064. Epub 2019 Mar 11. PMID: 30872154.
- Zuberbier T, Abdul Latiff AH, Abuzakouk M, et al. The international EAACI/GA(2)LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-766.
- Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA²LEN task force report. Allergy. 2011;66(3):317-330.
- Wagner N, Zink A, Hell K, et al. Patients with Chronic Urticaria Remain Largely Undertreated: Results from the DERMLINE Online Survey. Dermatol Ther (Heidelb). 2021;11(3):1027-1039.
- Goldstein, Stanley, Eftekhari, Sanaz, Mitchell Lynda, et al. Perspectives on Living with Chronic Spontaneous Urticaria: From Onset through Diagnosis and Disease Management in the US. Advances in dermatology and venereology, 2019;99:1091-1098.
- Huang Y, Xiao Y, Jing D, et al. Association of Chronic Spontaneous Urticaria With Anxiety and Depression in Adolescents: A Mediation Analysis. Front Psychiatry. 2021;12:655802.