Cold UrticariaPhase 1NCT04548869
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
A Phase 1 study testing CDX-0159 in people with Cold Urticaria and Cold Contact Urticaria, run by Celldex Therapeutics at 1 site in Germany.
Trial summary
This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism
- What is being tested?
- CDX-0159
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 24 Nov 2020to 12 May 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
- Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
- Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines
- During screening, in clinic, for Cold Contact Urticaria, patients must have a positive cold stimulation test, for Symptomatic Dermographism, patients must have a positive FricTest®, and for Cholinergic Urticaria, patients must have a positive pulse-controlled ergometry (PCE) provocation test
- On stable dose of 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
Who cannot join
- 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
- There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add on Therapy in Patients With Cold Contact Urticaria, Symptomatic Dermographism and Cholinergic Urticaria
This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
Read the detailed description
This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in four separate cohorts for a total of 40 patients.
Prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1. Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.
- Conditions
- Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria
- Being tested
- CDX-0159
- Medical subject headings
- Cold Urticaria, Familial dermographism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-0159Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| CDX-0159 | Experimental | 20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159 Receives: Drug: CDX-0159 |
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 a single dose of CDX-0159 as determined by adverse events
Measured: From Day 1 through week 12
Secondary outcomes (8)
For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)
The change from baseline in critical temperature thresholds over time as determined by provocation testing using the TempTest®
Measured: From Day 1 to Day 85
For patients with Symptomatic Dermographism, change in provocation thresholds
The change from baseline in provocation thresholds over time as determined by provocation testing using the FricTest®
Measured: From Day 1 to Day 85
For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
Changes from baseline and percentage of responders as measured by UASprovo
Measured: From Day 1 to Day 85
Changes from baseline in Urticaria Control Test (UCT)
Changes from baseline and percentage of responders for the UCT and modified UCT
Measured: From Day 1 to Day 85
Blood Biomarkers
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor
Measured: From Day 1 to Day 85
Blood Biomarkers
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase
Measured: From Day 1 to Day 85
Pharmacokinetic Evaluation
CDX-0159 concentrations will be measured.
Measured: From Day 1 to Day 85
Immunogenicity Evaluation
Patients will be monitored for the development of anti-drug antibodies.
Measured: From Day 1 to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start24 Nov 2020
- Primary completion16 Dec 2022
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT04548869
- Sponsor's protocol ID
- CDX0159-03
- Other IDs
- 2020-002792-35
- Status last verified
- May 2023
- First submitted
- 8 Sep 2020
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add on Therapy in Patients With Cold Contact Urticaria, Symptomatic Dermographism and Cholinergic Urticaria
- ClinicalTrials.gov ID
- NCT04548869
- Acronym / sponsor ID
- CDX0159-03
- Conditions
- Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 16 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 CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
Detailed description
This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in four separate cohorts for a total of 40 patients.
Prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1. Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-0159 | Experimental | Drug: CDX-015920 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
Primary outcome
Safety as assessed by the incidence and severity of adverse events
Time frame: From Day 1 through week 12
Safety of a single dose of CDX-0159 as determined by adverse events
8 secondary outcomes
For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)
Time frame: From Day 1 to Day 85
For patients with Symptomatic Dermographism, change in provocation thresholds
Time frame: From Day 1 to Day 85
For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
Time frame: From Day 1 to Day 85
Changes from baseline in Urticaria Control Test (UCT)
Time frame: From Day 1 to Day 85
Blood Biomarkers
Time frame: From Day 1 to Day 85
Blood Biomarkers
Time frame: From Day 1 to Day 85
Pharmacokinetic Evaluation
Time frame: From Day 1 to Day 85
Immunogenicity Evaluation
Time frame: From Day 1 to Day 85
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 17 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDX-0159 in people with Cold Urticaria and Cold Contact Urticaria, run by Celldex Therapeutics at 1 site in Germany.
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 7 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 through week 12). 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 17 May 2023.