CompletedPhase 1

A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria

Germany41 participantsStarted 2020-11-24

Plain-language summary

This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
✓. Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
✓. Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
✓. Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires

✕. A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
✕. Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
✕. Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
✕. Active COVID-19 infection
✕. HIV, hepatitis B or hepatitis C infection

Safety as assessed by the incidence and severity of adverse events

Timeframe: From Day 1 through week 12

NCT IDNCT04548869

SponsorCelldex Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-16

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
✓. Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
✓. Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
✓. Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires

✕. A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
✕. Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
✕. Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
✕. Active COVID-19 infection
✕. HIV, hepatitis B or hepatitis C infection