An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients with Chronic Cold Urticaria
- Conditions
- Cold hives10001708Cold urticaria
- Registration Number
- NL-OMON51543
- Lead Sponsor
- Third Harmonic Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
-Diagnosis of chronic cold urticaria for at least 3 months.
-Participants must be refractory to antihistamine treatment.
-Participants must understand the nature of the trial and must provide signed
and dated written informed consent in accordance with local regulations before
the conduct of any trial-related procedures.
-Participants currently on an antihistamine must be on a stable dose for at
least 2 weeks prior to day 1 and must maintain the same stable dose throughout
the treatment period.
-Positive cold stimulation test assessed by TempTest®
-Healthy as determined by the Investigator
-Men and women, age 18-75 years
-Women of child-bearing potential must not be pregnant or lactating. Women of
child-bearing potential and their non-vasectomized partners must agree to use
two of the following contraceptive methods during the trial and for 90 days
after the (last) trial drug administration: non-hormonal intra-uterine
device/system, condom, diaphragm, cervical cap with spermicide. Hormonal
contraceptives may continue to be used but are not considered a highly
effective form of birth control for this study.
OR Women of child-bearing potential and their vasectomized partners must agree
to use one of the following contraceptive methods during the trial and for 90
days after the (last) trial drug administration: non-hormonal intra-uterine
device/system, condom, diaphragm, cervical cap with spermicide. Hormonal
contraceptives may continue to be used but are not considered a highly
effective form of birth control for this study.
OR Women of child-bearing potential must practice sexual abstinence (when this
is in line with her preferred and usual lifestyle) during the trial and for 90
days after the (last) trial drug administration.
-Participants with acute urticaria and participants with non-cold chronic
inducible urticaria.
-Current/ongoing treatment with immunosuppressant drugs, leukotriene
antagonists, danazol, penicillin, angiotensin-converting inhibitors, and
griseofulvin
-Any previous treatment with CDX-0159.
-A positive test for drugs of abuse at Screening.
-A positive Hepatitis B surface antigen or positive Hepatitis C or human
immunodeficiency virus (HIV) antibody result at Screening.
-Abnormal clinically significant findings on the laboratory examinations at the
Screening (ALT, AST, TBL, greater than 1.5 times the upper limit of normal;
Hbg, platelet count, ANC, reticulocyte count, WBC, below the lower limit of
normal)
-Use of prescription or non-prescription drugs, vitamins, herbal, and dietary
supplements, unless in the opinion of the Investigator and the Medical Monitor
the medication will not interfere with the trial procedures or compromise
participant safety.
-Received or used an investigational product (including placebo) or device
within the following time period prior to the first dosing day in the current
trial: 90 days, 5 half-lives or twice the duration of the biological effect of
the investigational product (whichever is longer).
-A positive pregnancy test or lactation.
-A history or presence of a clinically significant hepatic, renal,
gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic,
immunologic, hematologic, dermatologic (other than chronic urticaria),or
neurologic abnormality.
-A clinically significant vital signs abnormality, as judged by the principal
investigator, at Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Treatment emergent AEs/SAEs<br /><br>• Laboratory assessments<br /><br>• ECG, vital signs</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Change from baseline in critical temperature threshold (CTT) over time using<br /><br>the TempTest® system<br /><br>• Percentage of complete responders (CTT <= 4°C) and partial responders<br /><br>(> 4°C CTT change from baseline) over time<br /><br>• Time to complete (partial) response<br /><br>• Pre- and post-treatment changes in skin mast cell density<br /><br>• Pre- and post-treatment changes in serum tryptase<br /><br><br /><br>• Plasma PK concentration of THB001 over time<br /><br>• Modeled plasma PK parameters of THB001 including but not limited to Cmax,<br /><br>Cmin and AUC as appropriate</p><br>