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A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

Primary Purpose

Chronic Inducible Urticaria

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
barzolvolimab
Matching Placebo
Sponsored by
Celldex Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inducible Urticaria focused on measuring CDX-0159, barzolvolimab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key inclusion criteria:

  1. Males and females, >/= 18 years of age.
  2. Diagnosis of chronic ColdU or SD >/= 3 months.

  3. Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

    1. Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
    2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment and agree to stay on through trial.
    3. UCT < 12 during the 14 days prior to treatment.

  4. Positive provocation test

    1. for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3)
    2. for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)
  5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
  6. Willing and able to complete a daily symptom electronic diary and comply with study visits.

Key exclusion criteria:

  1. Women who are pregnant or nursing.
  2. Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments.
  3. Active, pruritic skin condition in addition to CIndU.
  4. Medical condition that would cause additional risk or interfere with study procedures.
  5. Known active HIV, hepatitis B or hepatitis C infection.
  6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
  7. History of anaphylaxis

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Sites / Locations

  • Clinical Research Center of AlabamaRecruiting
  • Allervie Clinical Research
  • One of a Kind Clinical Research Center, LLCRecruiting
  • Little Rock Allergy & Asthma CRCRecruiting
  • Kern Research, IncRecruiting
  • Allergy & Asthma ConsultantsRecruiting
  • IMMUNOe Research CentersRecruiting
  • Sarasota Clinical Research
  • Treasure Valley Medical ResearchRecruiting
  • Dawes Fretzin Dermatology Group, LLCRecruiting
  • Allergy & Asthma Specialists, PSCRecruiting
  • Institute for Asthma and Allergy, PC/Department of Clinical ResearchRecruiting
  • Respiratory Medicine Research Institute of Michigan, PLCRecruiting
  • Allergy Partners of KerrvilleRecruiting
  • Allergy Associates of UtahRecruiting
  • Outpatient Clinic for Individual Practice for Specialized OutpatientRecruiting
  • Medical Center Iskar- EOOD Office of Clinical AllergologyRecruiting
  • "Medical Center Ekselsior" OODRecruiting
  • "University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical AllergologyRecruiting
  • Medical Center "SYNEXUS SOFIA", EOODRecruiting
  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" ADRecruiting
  • Vahlberg & Pild ClinicRecruiting
  • East Tallin Central HospitalRecruiting
  • High Technology Hospital MedcenterRecruiting
  • Healthy FutureRecruiting
  • Center of Allergy and ImmunologyRecruiting
  • Multiprofile Clinic Consilium MedullaRecruiting
  • Universitätsklinikum AugsburgRecruiting
  • LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien ZentrumRecruiting
  • Universitaetsklinikum Giessen u. Marburg GmbHRecruiting
  • Elbe Klinikum BuxtehudeRecruiting
  • Hannover Medical UniversityRecruiting
  • Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. AllergologieRecruiting
  • Universitätsklinikum Düsseldorf - DermatologieRecruiting
  • Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie HufelandstrRecruiting
  • Universitätsklinikum Münster Klinik u. Poliklinik f. DermatologieRecruiting
  • Universitätsklinikum DresdenRecruiting
  • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche HauterkrankungenRecruiting
  • Institute of Allergology IFARecruiting
  • Universitätsklinikum Heidelberg - DermatologieRecruiting
  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai KlinikaRecruiting
  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai KlinikaRecruiting
  • Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati KlinikaRecruiting
  • Allergo-Derm Bakos KftRecruiting
  • Óbudai Egészségügyi CentrumRecruiting
  • Balvi and Gulbene Hospital UnionRecruiting
  • Pauls Stradins Clinical University HospitalRecruiting
  • "LOR" ClinicRecruiting
  • Children Clinical University HospitalRecruiting
  • Consilium MedicumRecruiting
  • JSC Ausros Medicinos CentrasRecruiting
  • JSC InlitaRecruiting
  • Center of Allergy Diagnosis and TreatmentRecruiting
  • Centrum Medyczne PLEJADYRecruiting
  • Malopolskie Centrum AlergologiiRecruiting
  • Uniwersytecki Szpital Kliniczny nr 1 w LodziRecruiting
  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty KrasowskiejRecruiting
  • Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i AlergologiiRecruiting
  • Medicome Sp. z o.o.Recruiting
  • Medicover Integrated Clinical Services Sp. zo.o.Recruiting
  • Klinika Ambroziak sp. z o.o.Recruiting
  • Iatros InternationalRecruiting
  • WorthWhile Clinical TrialsRecruiting
  • Newtown Clinical ResearchRecruiting
  • Ubuntu Clinical ResearchRecruiting
  • FCRN Clinical Trial Centre Vaal TriangleRecruiting
  • Synapta Clinical ResearchRecruiting
  • Dr PJ SebastianRecruiting
  • The University of Cape Town - Lung InstituteRecruiting
  • HGU de AlicanteRecruiting
  • Hospital BellvitgeRecruiting
  • Hospital Vall d´ HebronRecruiting
  • Universidad de NavarraRecruiting
  • Hospital Regional Universitario de MálagaRecruiting
  • Hospital Arnau de VilanovaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

barzolvolimab 150 mg in patients with Symptomatic Dermographism

barzolvolimab 300 mg in patients with Symptomatic Dermographism

Placebo Comparator in patients with Symptomatic Dermographism

barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria

barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria

Placebo Comparator in patients with Chronic Inducible Cold Urticaria

Arm Description

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Placebo injection subcutaneous every 4 weeks for 20 weeks

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Placebo injection subcutaneous every 4 weeks for 20 weeks

Outcomes

Primary Outcome Measures

Percentage of patients with a negative provocation test at week 12
Percentage of patients with a negative provocation test for Cold Inducible Urticaria [ColdU] or Symptomatic Dermographism [SD]) at week 12 For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®

Secondary Outcome Measures

Change in provocation threshold and itch for ColdU
Mean change from baseline to week 12 in critical temperature threshold (CTT) in patients with ColdU CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark
Change in provocation threshold for SD
Mean change from baseline to Week 12 in Critical Friction Threshold (CFT) in patients with SD CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark
Change in worst itch reported after provocation for ColdU
Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with ColdU
Combined patients with a negative provocation test at week 12
Percentage of combined patients with a negative TempTest (ColdU) or FricTest (SD) at week 12
Change in worst itch reported after provocation for SD
Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD
Change in worst itch reported after provocation in both SD and ColdU
Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD and ColdU combined
Percentage of patients experiencing adverse events
Percentage of patients experiencing treatment-emergent adverse events (TEAE) examined by ColdU patients, SD patients and in combination. A TEAE is any untoward medical occurrence in a patient administered a study treatment.

Full Information

First Posted
June 1, 2022
Last Updated
September 29, 2023
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05405660
Brief Title
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
Official Title
: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.
Detailed Description
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria [ColdU] or Symptomatic Dermographism [SD]) who remain symptomatic despite the use of H1-antihistamines. There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inducible Urticaria
Keywords
CDX-0159, barzolvolimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
barzolvolimab 150 mg in patients with Symptomatic Dermographism
Arm Type
Experimental
Arm Description
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
Arm Title
barzolvolimab 300 mg in patients with Symptomatic Dermographism
Arm Type
Experimental
Arm Description
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
Arm Title
Placebo Comparator in patients with Symptomatic Dermographism
Arm Type
Placebo Comparator
Arm Description
Placebo injection subcutaneous every 4 weeks for 20 weeks
Arm Title
barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria
Arm Type
Experimental
Arm Description
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
Arm Title
barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria
Arm Type
Experimental
Arm Description
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
Arm Title
Placebo Comparator in patients with Chronic Inducible Cold Urticaria
Arm Type
Placebo Comparator
Arm Description
Placebo injection subcutaneous every 4 weeks for 20 weeks
Intervention Type
Biological
Intervention Name(s)
barzolvolimab
Other Intervention Name(s)
CDX-0159
Intervention Description
Subcutaneous Administration
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Subcutaneous Administration
Primary Outcome Measure Information:
Title
Percentage of patients with a negative provocation test at week 12
Description
Percentage of patients with a negative provocation test for Cold Inducible Urticaria [ColdU] or Symptomatic Dermographism [SD]) at week 12 For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
Change in provocation threshold and itch for ColdU
Description
Mean change from baseline to week 12 in critical temperature threshold (CTT) in patients with ColdU CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark
Time Frame
From baseline to week 12
Title
Change in provocation threshold for SD
Description
Mean change from baseline to Week 12 in Critical Friction Threshold (CFT) in patients with SD CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark
Time Frame
From baseline to week 12
Title
Change in worst itch reported after provocation for ColdU
Description
Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with ColdU
Time Frame
From baseline to week 12
Title
Combined patients with a negative provocation test at week 12
Description
Percentage of combined patients with a negative TempTest (ColdU) or FricTest (SD) at week 12
Time Frame
From baseline to week 12
Title
Change in worst itch reported after provocation for SD
Description
Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD
Time Frame
From baseline to week 12
Title
Change in worst itch reported after provocation in both SD and ColdU
Description
Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD and ColdU combined
Time Frame
From baseline to week 12
Title
Percentage of patients experiencing adverse events
Description
Percentage of patients experiencing treatment-emergent adverse events (TEAE) examined by ColdU patients, SD patients and in combination. A TEAE is any untoward medical occurrence in a patient administered a study treatment.
Time Frame
From baseline to week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria: Males and females, >/= 18 years of age. Diagnosis of chronic ColdU or SD >/= 3 months. Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by: Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment and agree to stay on through trial. UCT < 12 during the 14 days prior to treatment. Positive provocation test for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3) for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3) Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment. Willing and able to complete a daily symptom electronic diary and comply with study visits. Key exclusion criteria: Women who are pregnant or nursing. Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments. Active, pruritic skin condition in addition to CIndU. Medical condition that would cause additional risk or interfere with study procedures. Known active HIV, hepatitis B or hepatitis C infection. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. History of anaphylaxis There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celldex Therapeutics
Phone
844-723-9363
Email
info@celldex.com
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Scott
Email
bscott@allervie.com
Facility Name
Allervie Clinical Research
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Individual Site Status
Completed
Facility Name
One of a Kind Clinical Research Center, LLC
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Nelson
Email
anna@1-oak.net
Facility Name
Little Rock Allergy & Asthma CRC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindy DeMarco
Email
mdemarco@littlerockallergy.com
Facility Name
Kern Research, Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Boren
Email
ejboren@yahoo.com
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Lipson
Email
sherry.lipsonallergy@gmail.com
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Collins
Email
mcollins@immunoe.com
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Completed
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Hernandez
Email
ehernandez@tvmedresearch.com
Facility Name
Dawes Fretzin Dermatology Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elissa O´Malley
Email
eomalley@ecommunity.com
Facility Name
Allergy & Asthma Specialists, PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Hanes
Email
ahaynes@cloremd.com
Facility Name
Institute for Asthma and Allergy, PC/Department of Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Wan
Email
iaaresearchwan@gmail.com
Facility Name
Respiratory Medicine Research Institute of Michigan, PLC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Grigoryan
Email
dgrigoryan@annarborallergy.com
Facility Name
Allergy Partners of Kerrville
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dale Mohar
Email
dmohar@kerrresearch.com
Facility Name
Allergy Associates of Utah
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Warr
Email
sandy.warr@utahallergies.com
Facility Name
Outpatient Clinic for Individual Practice for Specialized Outpatient
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talyat Cholak
Email
raz35doc@abv.bg
Facility Name
Medical Center Iskar- EOOD Office of Clinical Allergology
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekaterina Nikolaeva Boyanina
Email
katy017@abv.bg
Facility Name
"Medical Center Ekselsior" OOD
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todor Popov
Email
ted.popov@gmail.com
Facility Name
"University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Staevska
Email
marikotasheva@gmail.com
Facility Name
Medical Center "SYNEXUS SOFIA", EOOD
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marinela Prokopova
Email
drprokopova@abv.bg
Facility Name
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadezhda Trungova
Email
nadezhda.trungova@clineca.net
Facility Name
Vahlberg & Pild Clinic
City
Tallinn
ZIP/Postal Code
10134
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ave Vahlberg
Email
avevahlberg@gmail.com
Facility Name
East Tallin Central Hospital
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krista Ress
Email
krista.ress@itk.ee
Facility Name
High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mamuladze
Email
davitalergo@gmail.com
Facility Name
Healthy Future
City
Tbilisi
ZIP/Postal Code
0119
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Ghughunishvili
Email
marighughu@yahoo.com
Facility Name
Center of Allergy and Immunology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maia Gotua
Email
maia.gotua@gmail.com
Facility Name
Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiantin Kavtaradze
Email
t.kavtaradze@smo-pharmina.net
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Welzel
Email
Julia.Welzel@uk-augsburg.de
Facility Name
LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
City
München
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Dobre
Email
laura.dobre@med.uni-muenchen.de
Facility Name
Universitaetsklinikum Giessen u. Marburg GmbH
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Cramer
Email
andrea.cramer@uk-gm.de
Facility Name
Elbe Klinikum Buxtehude
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annika Buchholtz
Email
Annika.Buchholtz@elbekliniken.de
Facility Name
Hannover Medical University
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Reh
Email
Reh.Heidi@mh-hannover.de
Facility Name
Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Fieber
Email
Fieber.Lena@klinikum-oldenburg.de
Facility Name
Universitätsklinikum Düsseldorf - Dermatologie
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Meller
Email
stephan.meller@med.uni-duesseldorf.de
Facility Name
Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wiebke Sondermann
Email
Wiebke.Sondermann@uk-essen.de
Facility Name
Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Kieslich
Email
katrin.kieslich@ukmuenster.de
Facility Name
Universitätsklinikum Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Blümlein
Email
Katharina.Bluemlein@ukdd.de
Facility Name
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido Heine
Email
gheine@dermatology.uni-kiel.de
Facility Name
Institute of Allergology IFA
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Maurer
Email
marcus.maurer@charite.de
Facility Name
Universitätsklinikum Heidelberg - Dermatologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kornelia Junge
Email
kornelia.junge@med.uni-heidelberg.de
Facility Name
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Péter Holló
Email
hollo.peter@med.semmelweis-univ.hu
Facility Name
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Péter Holló
Email
hollo.peter@med.semmelweis-univ.hu
Facility Name
Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emerencia Tokajine Szebenszki
Email
szebenszki.emerencia@med.unideb.hu
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noémi Bakos
Email
bakosnoemidr@gmail.com
Facility Name
Óbudai Egészségügyi Centrum
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szilvia Kovács
Email
szilvia.kovacs@oecresearch.com
Facility Name
Balvi and Gulbene Hospital Union
City
Balvi
ZIP/Postal Code
LV-4501
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarmite Puzule
Email
sarmite.puzule@gmail.com
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liga Ciekure
Email
liga.ciekure@inbox.lv
Facility Name
"LOR" Clinic
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dace Karklina
Email
karklina.dace@inbox.lv
Facility Name
Children Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanita Zigure
Email
sanita.zigure@gmail.com
Facility Name
Consilium Medicum
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maris Bukovskis
Email
mbukovskis@gmail.com
Facility Name
JSC Ausros Medicinos Centras
City
Kaunas
ZIP/Postal Code
49387
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edita Gasiūnienė
Email
edita.gasiuniene@gmail.com
Facility Name
JSC Inlita
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Malinauskienė
Email
linas.liekis@inlita.lt
Facility Name
Center of Allergy Diagnosis and Treatment
City
Vilnius
ZIP/Postal Code
LT-09109
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Slomskis
Email
tslomskis@gmail.com
Facility Name
Centrum Medyczne PLEJADY
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Gondek
Email
marta.gondek@plejady.com.pl
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31-624
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariola Rzymek
Email
maran66@interia.pl
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Molinska
Email
joanna.molinska@umed.lodz.pl
Facility Name
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej
City
Lublin
ZIP/Postal Code
20-573
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Pacion
Email
aleksandra.pacion86@gmail.com
Facility Name
Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
City
Opole
ZIP/Postal Code
45-401
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zenon Brzoza
Email
zenon.brzoza@uni.opole.pl
Facility Name
Medicome Sp. z o.o.
City
Oświęcim
ZIP/Postal Code
32600
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Olejniczak
Email
aolejniczak@medicome.pl
Facility Name
Medicover Integrated Clinical Services Sp. zo.o.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulina Strahl
Email
p.strahl@naszlekarz.pl
Facility Name
Klinika Ambroziak sp. z o.o.
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radoslaw Dzida
Email
r.dzida@klinikaambroziak.pl
Facility Name
Iatros International
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9324
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reinette Lourens
Email
reinet@iatros.co.za
Facility Name
WorthWhile Clinical Trials
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Taljaard
Email
jessica@wwct.co.za
Facility Name
Newtown Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2113
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farhaad Shaik
Email
farhaad@newtowncrc.co.za
Facility Name
Ubuntu Clinical Research
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustav Venter
Email
gustav.v@ubuntucr.co.za
Facility Name
FCRN Clinical Trial Centre Vaal Triangle
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1935
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charnel Engelbrecht
Email
charnel.engelbrecht@ctcvaal.co.za
Facility Name
Synapta Clinical Research
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freeda Saib
Email
fareeda@synapta.co.za
Facility Name
Dr PJ Sebastian
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4092
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kumeshni Varatharajalu
Email
kvaratharajalu10@gmail.com
Facility Name
The University of Cape Town - Lung Institute
City
Cape Town
State/Province
Mowbray
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Elizabeth Bush
Email
christine.bush@uct.ac.za
Facility Name
HGU de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Llorca
Email
eecc.derma.hgua@gmail.com
Facility Name
Hospital Bellvitge
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Garzon
Email
mgarzon.clinicaltrials@gmail.com
Facility Name
Hospital Vall d´ Hebron
City
Barcelona
ZIP/Postal Code
9035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Company Sapiña
Email
laura.company@vhir.org
Facility Name
Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Mercedes Romero Insuna
Email
mromeroi@unav.es
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria José Torres Jaén
Email
mjtorresj@gmail.com
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Gabarron
Email
Ajgague@outlook.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

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