Cold Contact UrticariaPhase 2CuresNCT02171416
Cold Contact Urticaria Treatment With Rilonacept
A Phase 2 study testing Rilonacept in people with Cold Contact Urticaria, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Contact Urticaria
- What is being tested?
- Rilonacept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2015to May 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ( > 18 years of age)
- Outpatients with CCU for more than six weeks. Urticaria symptoms must comprise wheal and itch and be resistant to conventional antihistamine treatment in standard doses
- Patients with a positive cold stimulation test at 4°C (assessed by TEMPtest 3.0)
- Informed consent signed and dated. Able to read, understand and willing to sign the informed consent form
- Able to read, understand and complete study-related questionnaires
- Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to self-administer SC injections or to have SC injections administered by a qualified person
Show all 13Show fewer
- In women, negative pregnancy test
- Reliable method of contraception for both women of childbearing potential as well as men, during the course of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- Subjects are considered eligible according to the following tuberculosis (TB) screening criteria:
- No history of latent or active TB prior to screening
- No signs or symptoms suggestive of active TB
- No recent close contacts with a person with active TB
- A negative QuantiFERON-TB test on day -14 (screening visit).
Who cannot join
- Treatment with a live (attenuated) virus vaccine during the month prior to day 0 (Randomization).
- A history of serious chronic or active infection(s) eg. listeriosis within six weeks prior to the screening visit.
- Evidence of acute or latent Tuberculosis as defined by the local guidelines/local medical practice
- A history of acute tuberculosis despite the proper treatment.
- Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, lymphatic or hematological disease that would adversely affect the subject's participation or evaluation in this study.
- Active systemic inflammatory condition including, but not limited to, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, vasculitis, or myositis.
Show all 19Show fewer
- History of fibromyalgia or chronic fatigue syndrome.
- Evidence of current HIV, Hepatitis B, or Hepatitis C infection by clinical or serological history.
- History of malignancies including malignant hematological disorders other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cervical cancer within five years of the Screening visit.
- Severe respiratory disease, including, but not limited to severe bronchiectasis, chronic obstructive pulmonary disease, bullous lung disease, uncontrolled asthma, or pulmonary fibrosis.
- Presence of any of the following laboratory abnormalities at enrollment visit: creatinine >1.5 x Upper Limit of Normal (ULN), WBC <3.6 x 103/mm3; platelet count <150,000 mm3; ALT or AST >2.0 x ULN.
- Previous ineffective treatment with IL1 inhibitor or other biologic agent.
- Known hypersensitivity to CHO cell derived therapeutics or proteins or any components of rilonacept.
- Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk.
- Present History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject's ability to comply with study procedures.
- Lactating females or pregnant females.
- Enrollment in another investigational treatment or device study or use of an investigational agent, or no completion of less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial.
- Subjects for whom there is concern about compliance with the protocol procedures.
- Subjects who are detained officially or legally to an official institute.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Berlin Charité ; Dermatology
Berlin, 10117
Universitätsmedizin
Mainz, 55131
About this study
Official title: A Single-center, Double-blind Placebo-controlled Parallel Group Phase II Study of the Efficacy and Safety of Rilonacept in Subjects With Cold Contact Urticaria (CCU)
Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Typically, symptoms occur within minutes after cold contact, including exposure to cold air, liquids or objects and are limited to cold exposed skin areas.
The investigators postulate that there is an overlap between acquired cold urticaria and cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to antihistamines will benefit from IL-1 targeting treatment strategies.
Read more
This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept in patients with cold contact urticaria who could not be successfully treated with first-line medication such as antihistamines.
This is a double-blind placebo-controlled parallel group phase II study of the efficacy and safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the Urticaria specialty clinics of ACC. The total duration of the study course for each patient is 14 weeks and is divided in:
- Screening period (2 weeks, days -14-0)
- Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42)
- Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and will receive the respective dose subcutaneously. Following the placebo-controlled double-blind phase patients will enter the open-label phase and receive rilonacept open-label treatment (160mg or 320mg depending on treatment response during part A).
- Conditions
- Cold Contact Urticaria
- Being tested
- Rilonacept, Placebo
- Medical subject headings
- Cold Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilonaceptDrug
Also called Arcalyst
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo s.c every 7 days Receives: Drug: Rilonacept |
| Rilonacept 160mg | Experimental | Rilonacept s.c every 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of rilonacept on the clinical signs and symptoms of CCU
Change in symptom development (critical temperature thresholds (CTT) in CCU patients from baseline to day 42 in the rilonacept group as compared to the placebo group
Measured: 6 weeks
Secondary outcomes (1)
To assess the safety of rilonacept in subjects with CCU
This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2015
- Primary completion28 Feb 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cold Contact UrticariaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Karoline Krause, Charite University, Berlin, Germany
- Investigators
- Karoline Krause, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171416
- Sponsor's protocol ID
- Cures
- Other IDs
- 2012-005726-30
- Acronym
- Cures
- Status last verified
- Mar 2018
- First submitted
- 13 Jun 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bonnekoh H, Butze M, Spittler S, Staubach P, Weller K, Scheffel J, Maurer M, Krause K. Inhibition of interleukin-1 with rilonacept is not effective in cold urticaria-Results of a randomized, placebo-controlled study. Clin Transl Allergy. 2023 Mar;13(3):e12226. doi: 10.1002/clt2.12226.
PubMed 36973954
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blind Placebo-controlled Parallel Group Phase II Study of the Efficacy and Safety of Rilonacept in Subjects With Cold Contact Urticaria (CCU)
- ClinicalTrials.gov ID
- NCT02171416
- Acronym / sponsor ID
- Cures / Cures
- Conditions
- Cold Contact Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Jan 2015
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Jun 2014 (estimated)
- 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.
Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Typically, symptoms occur within minutes after cold contact, including exposure to cold air, liquids or objects and are limited to cold exposed skin areas.
The investigators postulate that there is an overlap between acquired cold urticaria and cold-induced autoinflammatory syndromes, and that cold urticaria patients unresponsive to antihistamines will benefit from IL-1 targeting treatment strategies.
This study will evaluate the efficacy and safety of the IL-1 transfusion protein rilonacept in patients with cold contact urticaria who could not be successfully treated with first-line medication such as antihistamines.
This is a double-blind placebo-controlled parallel group phase II study of the efficacy and safety of rilonacept in subjects with CCU. A total of 20 patients will be included by the Urticaria specialty clinics of ACC. The total duration of the study course for each patient is 14 weeks and is divided in:
- Screening period (2 weeks, days -14-0)
- Placebo-controlled double-blind phase (Part A, 6 weeks, days 0-42)
- Open label phase (Part B, 6 weeks, days 42-84) All eligible patients will be randomized (1:1 randomization) to one of two groups: 1) Rilonacept 160mg/week or 2) Placebo, and will receive the respective dose subcutaneously. Following the placebo-controlled double-blind phase patients will enter the open-label phase and receive rilonacept open-label treatment (160mg or 320mg depending on treatment response during part A).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: RilonaceptPlacebo s.c every 7 days |
| Rilonacept 160mg | Experimental | Drug: PlaceboRilonacept s.c every 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult ( > 18 years of age)
- Outpatients with CCU for more than six weeks. Urticaria symptoms must comprise wheal and itch and be resistant to conventional antihistamine treatment in standard doses
- Patients with a positive cold stimulation test at 4°C (assessed by TEMPtest 3.0)
- Informed consent signed and dated. Able to read, understand and willing to sign the informed consent form
- Able to read, understand and complete study-related questionnaires
Key exclusion criteria (19 listed)
- Treatment with a live (attenuated) virus vaccine during the month prior to day 0 (Randomization).
- A history of serious chronic or active infection(s) eg. listeriosis within six weeks prior to the screening visit.
- Evidence of acute or latent Tuberculosis as defined by the local guidelines/local medical practice
- A history of acute tuberculosis despite the proper treatment.
- Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, lymphatic or hematological disease that would adversely affect the subject's participation or evaluation in this study.
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 |
|---|---|---|
| RilonaceptAlso: Arcalyst | Drug | Placebo |
| Placebo | Drug | Rilonacept 160mg |
Primary outcome
To assess the effect of rilonacept on the clinical signs and symptoms of CCU
Time frame: 6 weeks
Change in symptom development (critical temperature thresholds (CTT) in CCU patients from baseline to day 42 in the rilonacept group as compared to the placebo group
1 secondary outcome
To assess the safety of rilonacept in subjects with CCU
Time frame: 6 weeks
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 Jul 2018.
- Derived from this study: PubMed 36973954Bonnekoh H, Butze M, Spittler S, Staubach P, Weller K, Scheffel J, Maurer M, Krause K. Inhibition of interleukin-1 with rilonacept is not effective in cold urticaria-Results of a randomized, placebo-controlled study. Clin Transl Allergy. 2023 Mar;13(3):e12226. doi: 10.1002/clt2.12226.
- Individual participant dataSharing planned: Undecided
Related trials for Cold Contact Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Chronic Inducible Urticaria
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
RecruitingObservational study
Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases (NOMID/CAPS, DIRA, CANDLE, SAVI, NLRC4-MAS, Still'S-like Diseases, and Other Undifferentiated Autoinflammatory Diseases)
NOMID, DIRA
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.
Karoline Krause, MD principal investigator
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rilonacept in people with Cold Contact Urticaria, run by Charite University, Berlin, Germany at 2 sites 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 13 inclusion and 19 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the effect of rilonacept on the clinical signs and symptoms of CCU (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171416, which also lists 1 linked publication.
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 Jul 2018.