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A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Primary Purpose

Chronic Spontaneous Urticaria

Status
Active
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 Spontaneous 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 spontaneous urticaria (CSU) >/= 6 months.

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

    1. The presence of hives 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.
    3. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment.
  4. Normal blood counts and liver function tests
  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. Clearly defined cause for chronic urticaria.
  3. Active, pruritic skin condition in addition to CSU.
  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
  8. Prior treatment with barzolvolimab

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 Alabama dba Allervie Clinical Research
  • Allervie Clinical Research
  • Medical Research of Arizona
  • Little Rock Allergy & Asthma CRC
  • Kern Research, Inc
  • Allergy & Asthma Consultants
  • IMMUNOe Research Centers
  • Treasure Valley Medical Research
  • Dawes Fretzin Clinical Research
  • Allergy & Asthma Specialists, PSC
  • Institute for Asthma and Allergy
  • Chesapeake Clinical Research
  • Respiratory Medicine Research Institute of Michigan, PLC
  • University of Nebraska Medical Center
  • Montefiore Medical Center/Subspeciality-Allergy and Immunology
  • Allergy Partners of Kerrville
  • "Diagnostic Consultative Center Pulmed" EOOD
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
  • Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
  • Medical Center Ekselsior OOD
  • "University Multiprofile Hospital for Active Treatment "Aleksandrovska EAD
  • Medical Center Iskar EOOD Office of Clinical Allergology
  • Medical Center "SYNEXUS SOFIA", EOOD
  • "Diagnostic Consultative Center Ritam TR" OOD Stara Zagora
  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD
  • Vahlberg & Pild Clinic
  • East Tallinn Central Hospital
  • High Technology Hospital Medcenter
  • Healthy Future
  • Center of Allergy and Immunology
  • Multiprofile Clinic Consilium Medulla
  • Universitätsklinikum Augsburg
  • LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
  • Universitaetsklinikum Giessen u. Marburg GmbH
  • Elbe Klinikum Buxtehude
  • Hannover Medical University
  • Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
  • Universitätsklinikum Düsseldorf - Dermatologie
  • Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr. 55
  • Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
  • Medical Center Quedlinburg - Dept. f. Dermatologie
  • Universitätsklinikum Dresden
  • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
  • Charite - Institute of Allergology IFA Campus Benjamin Franklin
  • Universitätsklinikum Heidelberg - Dermatologie
  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
  • Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
  • Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
  • Óbudai Egészségügyi Centrum Kft.
  • Centrum Medyczne Plejady
  • Malopolskie Centrum Alergologii
  • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie
  • Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
  • Medicome Sp. z o.o.
  • Medicover Integrated Clinical Services Sp. Z.o.o.
  • Klinika Ambroziak sp. z o.o.
  • Iatros International
  • WorthWhile Clinical Trials
  • Newtown Clinical Research
  • Ubuntu Clinical Research
  • FCRN Clinical Trial Centre Vaal Triangle
  • Synapta Clinical Research
  • Dr Pj Sebastian
  • The University of Cape Town - Lung Institute
  • Hospital General Universitario de Alicante
  • Hospital del Mar
  • Hospital Vall d´Hebron
  • Hospital Bellvitge
  • Universidad de Navarra
  • Hospital Regional Universitario de Málaga
  • Hospital Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

barzolvolimab 75 mg then 150 mg

barzolvolimab 75 mg then 300 mg

barzolvolimab 150 mg

barzolvolimab 300 mg

Placebo then barzolvolimab 150 mg

Placebo then barzolvolimab 300 mg

Arm Description

barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks

barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks

Outcomes

Primary Outcome Measures

Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None = mild (present, but not annoying or troublesome) = moderate (troublesome, but does not interfere with normal daily activity or sleep) = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep) Hives severity score (HSS) is on a scale of 0 - 3. 0 = None = less than 20 hives = between 20 and 50 hives = greater than 50 hives

Secondary Outcome Measures

Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)
AAS captures the presences of swelling over the last 24 hours and rates the severity with 5 questions. The possible range of the weekly score is 0 - 105.

Full Information

First Posted
May 5, 2022
Last Updated
July 17, 2023
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05368285
Brief Title
A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Spontaneous Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2025 (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 Spontaneous Urticaria
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 Spontaneous Urticaria. There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous 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
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
barzolvolimab 75 mg then 150 mg
Arm Type
Experimental
Arm Description
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks
Arm Title
barzolvolimab 75 mg then 300 mg
Arm Type
Experimental
Arm Description
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks
Arm Title
barzolvolimab 150 mg
Arm Type
Experimental
Arm Description
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks
Arm Title
barzolvolimab 300 mg
Arm Type
Experimental
Arm Description
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks
Arm Title
Placebo then barzolvolimab 150 mg
Arm Type
Experimental
Arm Description
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks
Arm Title
Placebo then barzolvolimab 300 mg
Arm Type
Experimental
Arm Description
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 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
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Description
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None = mild (present, but not annoying or troublesome) = moderate (troublesome, but does not interfere with normal daily activity or sleep) = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep) Hives severity score (HSS) is on a scale of 0 - 3. 0 = None = less than 20 hives = between 20 and 50 hives = greater than 50 hives
Time Frame
From baseline to Day 85 (Week 12)
Secondary Outcome Measure Information:
Title
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
Description
ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Time Frame
From baseline to Day 85 (Week 12)
Title
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
Description
HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Time Frame
From baseline to Day 85 (Week 12)
Title
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)
Description
AAS captures the presences of swelling over the last 24 hours and rates the severity with 5 questions. The possible range of the weekly score is 0 - 105.
Time Frame
From baseline to Day 85 (Week 12)

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 spontaneous urticaria (CSU) >/= 6 months. Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by: The presence of hives 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. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment. Normal blood counts and liver function tests 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. Clearly defined cause for chronic urticaria. Active, pruritic skin condition in addition to CSU. 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 Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Facility Information:
Facility Name
Clinical Research Center of Alabama dba Allervie Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Allervie Clinical Research
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Medical Research of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Little Rock Allergy & Asthma CRC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Kern Research, Inc
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Allergy & Asthma Consultants
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Dawes Fretzin Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Allergy & Asthma Specialists, PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Institute for Asthma and Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Chesapeake Clinical Research
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Respiratory Medicine Research Institute of Michigan, PLC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Montefiore Medical Center/Subspeciality-Allergy and Immunology
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Allergy Partners of Kerrville
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
"Diagnostic Consultative Center Pulmed" EOOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
Medical Center Ekselsior OOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
"University Multiprofile Hospital for Active Treatment "Aleksandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center Iskar EOOD Office of Clinical Allergology
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
Medical Center "SYNEXUS SOFIA", EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
"Diagnostic Consultative Center Ritam TR" OOD Stara Zagora
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Vahlberg & Pild Clinic
City
Tallinn
ZIP/Postal Code
10134
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Facility Name
Healthy Future
City
Tbilisi
ZIP/Postal Code
0119
Country
Georgia
Facility Name
Center of Allergy and Immunology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
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
Facility Name
Universitaetsklinikum Giessen u. Marburg GmbH
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
Elbe Klinikum Buxtehude
City
Buxtehude
State/Province
Niedersachsen
ZIP/Postal Code
21614
Country
Germany
Facility Name
Hannover Medical University
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf - Dermatologie
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr. 55
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medical Center Quedlinburg - Dept. f. Dermatologie
City
Quedlinburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
6484
Country
Germany
Facility Name
Universitätsklinikum Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1307
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite - Institute of Allergology IFA Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Heidelberg - Dermatologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Óbudai Egészségügyi Centrum Kft.
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31-624
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie
City
Lublin
ZIP/Postal Code
20-573
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
City
Opole
ZIP/Postal Code
45-401
Country
Poland
Facility Name
Medicome Sp. z o.o.
City
Oświęcim
ZIP/Postal Code
21-600
Country
Poland
Facility Name
Medicover Integrated Clinical Services Sp. Z.o.o.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Klinika Ambroziak sp. z o.o.
City
Warsaw
ZIP/Postal Code
02-953
Country
Poland
Facility Name
Iatros International
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9324
Country
South Africa
Facility Name
WorthWhile Clinical Trials
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Newtown Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Ubuntu Clinical Research
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
FCRN Clinical Trial Centre Vaal Triangle
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1935
Country
South Africa
Facility Name
Synapta Clinical Research
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Dr Pj Sebastian
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
The University of Cape Town - Lung Institute
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d´Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Bellvitge
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Universidad de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

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