Chronic Spontaneous UrticariaPhase 1NCT04538794
A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
A Phase 1 study testing CDX-0159 and Normal Saline in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 14 sites in 2 countries.
Trial summary
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- CDX-0159 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 24 Sep 2020to 17 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 - 75 years old.
- Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by:
- Diagnosis of CSU for >/= 6 months.
- The presence of itch and hives for >/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.
- UAS7 of >/= 16 and HSS7 of >/= 8 during the 7 days before treatment
- In-clinic UAS >/= 4 on one of the screening visit days
Show all 11Show fewer
- Use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study.
- Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
- 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 afterwards after treatment.
- Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Who cannot join
- Women who are pregnant or nursing.
- Cleary defined cause for chronic urticaria.
- Known HIV, hepatitis B or hepatitis C infection.
- Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection.
- History of anaphylaxis.
- There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Treasure Valley Medical Research
Boise, Idaho, 83706
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
AARA Research
Dallas, Texas, 75231
Asthma, Nasal Disease & Allergy Research Center of New England
East Providence, Rhode Island, 02914
Arizona Allergy & Immunology Research
Gilbert, Arizona, 85234
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250
Midwest Allergy, Sinus and Asthma, SC
Normal, Illinois, 61761
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
Kanarek Allergy Asthma & Immunology
Overland Park, Kansas, 66211
Sarasota Clinical Research
Sarasota, Florida, 34239
ForCare Clinical Research
Tampa, Florida, 33613
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136-7028
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Read the detailed description
The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.
There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- CDX-0159, Normal Saline
- Keywords
- CDX-0159
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-0159Drug
Administered intravenously
Normal SalineDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| CDX-0159 | Experimental | CDX-0159 every 4-8 weeks Receives: Drug: CDX-0159 |
| Normal Saline | Placebo comparator | Normal saline every 4-8 weeks Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by the incidence and severity of adverse events
Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events
Measured: From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary outcomes (8)
Pharmacokinetic evaluation
CDX-0159 serum concentrations will be measured at specified visits
Measured: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo
Measured: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo
Measured: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo
Measured: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo
Measured: Day 1 (first dose) to Day 169 (last follow up visit)
Pharmacodynamic evaluation
The effect of CDX-0159 on stem cell factor levels
Measured: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
The effect of CDX-0159 on tryptase
Measured: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Safety evaluation
Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies
Measured: From Day 1 (before dosing) to Day 169 (last follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start24 Sep 2020
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538794
- Sponsor's protocol ID
- CDX0159-02
- Other IDs
- 2020-005426-29
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2020
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT04538794
- Acronym / sponsor ID
- CDX0159-02
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- CDX-0159
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
Detailed description
The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.
There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDX-0159 | Experimental | Drug: CDX-0159CDX-0159 every 4-8 weeks |
| Normal Saline | Placebo comparator | Drug: Normal SalineNormal saline every 4-8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females, 18 - 75 years old.
- Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by:
- Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
- 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 afterwards after treatment.
Key exclusion criteria (6 listed)
- Women who are pregnant or nursing.
- Cleary defined cause for chronic urticaria.
- Known HIV, hepatitis B or hepatitis C infection.
- Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection.
- History of anaphylaxis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDX-0159Administered intravenously | Drug | CDX-0159 |
| Normal SalineAdministered intravenously | Drug | Normal Saline |
Primary outcome
Safety as assessed by the incidence and severity of adverse events
Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events
8 secondary outcomes
Pharmacokinetic evaluation
Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Time frame: Day 1 (first dose) to Day 169 (last follow up visit)
Pharmacodynamic evaluation
Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Safety evaluation
Time frame: From Day 1 (before dosing) to Day 169 (last follow-up visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDX-0159 and Normal Saline in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by the incidence and severity of adverse events (time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.