Symptomatic DermographismPhase 2UFONCT02169115
Urticaria Facticia Treatment With Omalizumab (UFO)
A Phase 2 study testing Omalizumab in people with Symptomatic Dermographism, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
Urticaria is a very frequent skin condition characterized by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms, which either occur spontaneously, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Dermographism
- What is being tested?
- Omalizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults (18-75 years)
- Informed consent signed and dated
- Able to read, understand and willing to sign the informed consent form and abide with study procedures
- Diagnosis of UF lasting for at least 6 months
- Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
- In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
- No participation in other clinical trials 4 weeks before and after participation in this study
Who cannot join
- Patients with acute urticaria
- Concurrent/ongoing treatment with immunosuppressives (e.g. systemic steroids, cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
- Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
- History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
- Presence of clinically significant laboratory abnormalities
Show all 16Show fewer
- Lactating females or pregnant females
- Subjects for whom there is concern about compliance with the protocol procedures
- Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
- History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures
- Subjects who are detained officially or legally to an official institute
- Previous use of omalizumab within the last 6 months
- Intake of antihistamines or leukotriene antagonists within 4 days prior to visit 1
- Intake of oral corticosteroids within 14 days prior to visit 1
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
- Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Dermatology Freiburg
Freiburg im Breisgau, 79104
Dermatology University Mainz
Mainz, 55131
About this study
Official title: Double-blind, Placebo-controlled 12-week, Parallel-group Study With a 6 Weeks Follow up Period to Demonstrate Efficacy and Safety of Subcutaneous Omalizumab in Patients With Urticaria Factitia Refractory to Standard Treatment
Urticaria is a very frequent skin condition characterized by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms, which either occur spontaneously, i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia (also known as dermographic urticaria and symptomatic dermographism) is characterized by whealing and itching following a minor stroking pressure, rubbing or scratching of the skin. The majority of patients with urticaria factitia benefits from treatment with nonsedating antihistamines. Some patients, however, do not achieve adequate symptom control even with updosing of antihistamines and may suffer from substantial quality of life impairment . Since even very minor stroking of the skin can lead to the development of wheals and severe itching, these patients are for example limited in their choice of clothing and are impaired in their social interaction and partnership.
In all patients with a history of wheals after stroking of the skin, a provocation test should be performed. This can be done by stroking of the skin lightly with a smooth blunt object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the smooth blunt object should be held perpendicular to the skin and should be used to apply a light stroking pressure to the skin of the upper back or volar forearm. The reaction is considered positive in patients who show a weal response and report pruritus at the site of provocation.
Patients with a positive test reaction should be evaluated for individual pressure thresholds. For this purpose a provocation device (FricTest) has been developed that allows for reproducible and standardized threshold testing. Threshold testing enables physicians to assess disease severity and treatment response more precisely.
- Conditions
- Symptomatic Dermographism
- Being tested
- Omalizumab, Placebo
- Medical subject headings
- Familial dermographism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
150mg, s.c., every 4 weeks
OmalizumabDrug
Also called Xolair
300mg, s.c., every 4 weeks
PlaceboDrug
Placebo, s.c., every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab 150mg | Experimental | Not described Receives: Drug: Omalizumab |
| Omalizumab 300mg | Experimental | Not described Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo
Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.
Measured: 70 days
Secondary outcomes (6)
To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life
Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percantage of the maximum possible score of 30.
Measured: 70 days
To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days
Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo
Measured: 70 days
To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity
Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo. VAS are measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. The scale ranges from a minimum of 0 and a maximum of 10. The higher the score, the worse the outcome.
Measured: 70 days
To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity
Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo. VAS are measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. The scale ranges from a minimum of 0 and a maximum of 10. The higher the score, the worse the outcome.
Measured: 70 days
To Assess Long-term Effects of Omalizumab in UF Patients
To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed
Measured: 112 days
Number of Participants With Serious Adverse Events and Adverse Events
Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic DermographismStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Martin Metz, Charite University, Berlin, Germany
- Investigators
- Martin Metz, MD, Principal investigator, Charité University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169115
- Sponsor's protocol ID
- CIGE025EDE17T
- Other IDs
- 2011-005615-87
- Acronym
- UFO
- Status last verified
- Oct 2020
- First submitted
- 12 Jun 2014
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maurer M, Schutz A, Weller K, Schoepke N, Peveling-Oberhag A, Staubach P, Muller S, Jakob T, Metz M. Omalizumab is effective in symptomatic dermographism-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017 Sep;140(3):870-873.e5. doi: 10.1016/j.jaci.2017.01.042. Epub 2017 Apr 4. No abstract available.
PubMed 28389391
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled 12-week, Parallel-group Study With a 6 Weeks Follow up Period to Demonstrate Efficacy and Safety of Subcutaneous Omalizumab in Patients With Urticaria Factitia Refractory to Standard Treatment
- ClinicalTrials.gov ID
- NCT02169115
- Acronym / sponsor ID
- UFO / CIGE025EDE17T
- Conditions
- Symptomatic Dermographism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 18 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urticaria is a very frequent skin condition characterized by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms, which either occur spontaneously, i.e. in chronic spontaneous urticaria (CSU), or as a result of environmental physical stimuli such as friction, pressure, UV irradiation or cold (physical urticaria). Urticaria factitia (also known as dermographic urticaria and symptomatic dermographism) is characterized by whealing and itching following a minor stroking pressure, rubbing or scratching of the skin. The majority of patients with urticaria factitia benefits from treatment with nonsedating antihistamines. Some patients, however, do not achieve adequate symptom control even with updosing of antihistamines and may suffer from substantial quality of life impairment . Since even very minor stroking of the skin can lead to the development of wheals and severe itching, these patients are for example limited in their choice of clothing and are impaired in their social interaction and partnership.
In all patients with a history of wheals after stroking of the skin, a provocation test should be performed. This can be done by stroking of the skin lightly with a smooth blunt object (e.g. the tip of a closed ball point pen or a wooden spatula) or a purpose-built instrument, known as a dermographometer. For the diagnosis of symptomatic dermographism, the smooth blunt object should be held perpendicular to the skin and should be used to apply a light stroking pressure to the skin of the upper back or volar forearm. The reaction is considered positive in patients who show a weal response and report pruritus at the site of provocation.
Patients with a positive test reaction should be evaluated for individual pressure thresholds. For this purpose a provocation device (FricTest) has been developed that allows for reproducible and standardized threshold testing. Threshold testing enables physicians to assess disease severity and treatment response more precisely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omalizumab 150mg | Experimental | Drug: Omalizumab |
| Omalizumab 300mg | Experimental | Drug: Omalizumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (18-75 years)
- Informed consent signed and dated
- Able to read, understand and willing to sign the informed consent form and abide with study procedures
- Diagnosis of UF lasting for at least 6 months
- Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
Key exclusion criteria (16 listed)
- Patients with acute urticaria
- Concurrent/ongoing treatment with immunosuppressives (e.g. systemic steroids, cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
- Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
- History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
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 |
|---|---|---|
| OmalizumabAlso: Xolair150mg, s.c., every 4 weeks | Drug | Omalizumab 150mg |
| OmalizumabAlso: Xolair300mg, s.c., every 4 weeks | Drug | Omalizumab 300mg |
| PlaceboPlacebo, s.c., every 4 weeks | Drug | Placebo |
Primary outcome
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo
Time frame: 70 days
Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.
6 secondary outcomes
To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life
Time frame: 70 days
To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days
Time frame: 70 days
To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity
Time frame: 70 days
To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity
Time frame: 70 days
To Assess Long-term Effects of Omalizumab in UF Patients
Time frame: 112 days
Number of Participants With Serious Adverse Events and Adverse Events
Time frame: 112 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28389391Maurer M, Schutz A, Weller K, Schoepke N, Peveling-Oberhag A, Staubach P, Muller S, Jakob T, Metz M. Omalizumab is effective in symptomatic dermographism-results of a randomized placebo-controlled trial. J Allergy Clin Immunol. 2017 Sep;140(3):870-873.e5. doi: 10.1016/j.jaci.2017.01.042. Epub 2017 Apr 4. No abstract available.
Related trials for Symptomatic Dermographism
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Skin Diseases, Angio-Oedema and/or Urticaria
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.
Martin Metz, MD principal investigator
Charité University
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 Omalizumab in people with Symptomatic Dermographism, 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 7 inclusion and 16 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 3 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo (time frame: 70 days). 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 NCT02169115, 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 3 Nov 2020.