Cold hives Cold urticaria
Conditions
Interventions
THB001 200 mg BID for 12 weeks
THB001 300 mg BID for 12 weeks
THB001 400 mg BID for 12 weeks
Sponsors
Third Harmonic Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Treatment emergent AEs/SAEs • Laboratory assessments • ECG, vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change from baseline in critical temperature threshold (CTT) over time using the TempTest® system • Percentage of complete responders (CTT 4°C CTT change from baseline) over time • Time to complete (partial) response • Pre- and post-treatment changes in skin mast cell density • Pre- and post-treatment changes in serum tryptase • Plasma PK concentration of THB001 over time • Modeled plasma PK parameters of THB001 including but not limited to Cmax, Cmin and AUC as appropriate | — |
Countries
Netherlands
Outcome results
None listed