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

Chronic Spontaneous Urticaria Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05368285
• Other study ID #: CDX0159-06
• Secondary ID: 2021-006413-11
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 19, 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: March 2025
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Biological:
• barzolvolimab
Subcutaneous Administration

Drug:
• Matching Placebo
Subcutaneous Administration

Locations

Country	Name	City	State
Bulgaria	"Diagnostic Consultative Center Pulmed" EOOD	Plovdiv
Bulgaria	University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD	Plovdiv
Bulgaria	Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD	Razgrad
Bulgaria	Medical Center "SYNEXUS SOFIA", EOOD	Sofia
Bulgaria	Medical Center Iskar EOOD Office of Clinical Allergology	Sofia
Estonia	Vahlberg & Pild Clinic	Tallinn
Georgia	Center of Allergy and Immunology	Tbilisi
Georgia	Healthy Future	Tbilisi
Georgia	Multiprofile Clinic Consilium Medulla	Tbilisi
Germany	Charite - Institute of Allergology IFA Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Dresden	Dresden	Sachsen
Germany	Universitätsklinikum Düsseldorf - Dermatologie	Düsseldorf	Nordrhein-Westfalen
Germany	Hannover Medical University	Hannover	Niedersachsen
Germany	Universitätsklinikum Heidelberg - Dermatologie	Heidelberg
Germany	Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Giessen u. Marburg GmbH	Marburg	Hessen
Germany	LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum	München	Bayern
Germany	Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie	Münster	Nordrhein-Westfalen
Germany	Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie	Oldenburg	Niedersachsen
Hungary	Semmelweis Egyetem, ÁOK, Bor-, Nemikórtani és Boronkológiai Klinika	Budapest
Hungary	Debreceni Egyetem, ÁOK és KK, Borgyógyászati Tanszék és Borgyógyászati Klinika	Debrecen
Hungary	Allergo-Derm Bakos Kft. Borgyógyászati Magánrendelo	Szolnok
Hungary	Óbudai Egészségügyi Centrum Kft.	Zalaegerszeg
Poland	Centrum Medyczne Plejady	Krakow
Poland	Malopolskie Centrum Alergologii	Krakow
Poland	Uniwersytecki Szpital Kliniczny nr 1 w Lodzi	Lodz
Poland	Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie	Lublin
Poland	Uniwersytecki Szpital Kliniczny w Opolu, Pododdzial Chorób Wewnetrznych i Alergologii	Opole
Poland	Medicome Sp. z o.o.	Oswiecim
Poland	Medicover Integrated Clinical Services Sp. Z.o.o.	Torun
Poland	Klinika Ambroziak sp. z o.o.	Warsaw
South Africa	WorthWhile Clinical Trials	Benoni	Gauteng
South Africa	Iatros International	Bloemfontein	Free State
South Africa	The University of Cape Town - Lung Institute	Cape Town
South Africa	Dr Pj Sebastian	Durban	KwaZulu-Natal
South Africa	Synapta Clinical Research	Durban	KwaZulu-Natal
South Africa	Newtown Clinical Research	Johannesburg	Gauteng
South Africa	Ubuntu Clinical Research	Lenasia	Gauteng
South Africa	FCRN Clinical Trial Centre Vaal Triangle	Vereeniging	Gauteng
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Bellvitge	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Universidad de Navarra	Madrid
United States	Kern Research, Inc	Bakersfield	California
United States	Clinical Research Center of Alabama dba Allervie Clinical Research	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Montefiore Medical Center/Subspeciality-Allergy and Immunology	Bronx	New York
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	Institute for Asthma and Allergy	Chevy Chase	Maryland
United States	Little Rock Allergy & Asthma CRC	Little Rock	Arkansas
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Allergy & Asthma Specialists, PSC	Owensboro	Kentucky
United States	Allergy & Asthma Consultants	Redwood City	California
United States	Medical Research of Arizona	Scottsdale	Arizona
United States	Chesapeake Clinical Research	White Marsh	Maryland
United States	Respiratory Medicine Research Institute of Michigan, PLC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Countries where clinical trial is conducted

United States,  Bulgaria,  Estonia,  Georgia,  Germany,  Hungary,  Poland,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From baseline to Day 85 (Week 12)
Secondary	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.	From baseline to Day 85 (Week 12)
Secondary	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.	From baseline to Day 85 (Week 12)
Secondary	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.	From baseline to Day 85 (Week 12)