Chronic Idiopathic UrticariaPhase 2NCT01599637
Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment
A Phase 2 study testing IGE025 in people with Chronic Idiopathic Urticaria, run by Novartis Pharmaceuticals at 4 sites in Germany.
Trial summary
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- IGE025
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesGermany
- Study dates
- Apr 2012to Sep 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline
Who cannot join
- Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact, as well as the following diseases as these diseases may have symptoms of urticaria or angioedema: Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer.
- Previous treatment with omalizumab.
- A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Münster, 48149
About this study
Official title: A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Determine the Mode of Action of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- IGE025, placebo
- Keywords
- Chronic idiopathic urticaria, CIU, Xolair, IGE025, FcεRI, IgE
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGE025Drug
Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
placeboDrug
Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
| Study group | Role | What they receive |
|---|---|---|
| IGE025 | Experimental | Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center. Receives: Drug: IGE025 |
| Placebo to IGE025 | Placebo comparator | Placebo administered subcutaneously every 4 weeks at the study center. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Measured: Baseline through Day 85 post-treatment
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Measured: Baseline through Day 85 post-treatment
Secondary outcomes (19)
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.
Measured: Baseline through Day 85
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.
Measured: Baseline through Day 85
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit
The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Measured: Baseline to Day 85
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit
Measured: Baseline through Day 85
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.
Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.
Measured: Baseline through Day 85
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.
Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.
Measured: Baseline through Day 85
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set
The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Measured: Baseline
Serum Levels of Omalizumab
Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks
Measured: Baseline through Day 85
Mean (SD) Serum Total IgE Concentration From Baseline by Visit
Measured: Baseline through Day 85
Mean (SD) Serum Total IgE % Change From Baseline by Visit
Measured: Baseline through Day 85
Mean (SD) Serum Free IgE Concentration From Baseline by Visit
Measured: Baseline through Day 85
Mean (SD) Serum Free IgE % Change From Baseline by Visit
Measured: Baseline through Day 85
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit
Measured: Baseline through Day 140
Change From Baseline in Urticaria Activity Score (UAS7)
Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.
Measured: Baseline, Day 85
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment
The investigator or the person he or she designated and the patient provided scoring of the patient's global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient's condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe
Measured: Baseline, Day 85
Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment
Measured: Day 29 to Day 85
Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment
The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. 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 percentage of the maximum possible score of 30.
Measured: Baseline through Day 85
Skindex-29 by Treatment
The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients' quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.
Measured: Baseline and Day 85
Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment
The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.
Measured: Baseline and 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 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionSep 2013
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 Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599637
- Sponsor's protocol ID
- CIGE025E2201
- Other IDs
- 2011-004216-31
- Status last verified
- Oct 2014
- First submitted
- 25 Jan 2012
- Last updated
- 31 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Metz M, Torene R, Kaiser S, Beste MT, Staubach P, Bauer A, Brehler R, Gericke J, Letzkus M, Hartmann N, Erpenbeck VJ, Maurer M. Omalizumab normalizes the gene expression signature of lesional skin in patients with chronic spontaneous urticaria: A randomized, double-blind, placebo-controlled study. Allergy. 2019 Jan;74(1):141-151. doi: 10.1111/all.13547. Epub 2018 Oct 15.
PubMed 29974963
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Determine the Mode of Action of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
- ClinicalTrials.gov ID
- NCT01599637
- Acronym / sponsor ID
- CIGE025E2201
- Conditions
- Chronic Idiopathic Urticaria
- Keywords
- Chronic idiopathic urticaria, CIU, Xolair, IGE025, FcεRI, IgE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 3 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGE025 | Experimental | Drug: IGE025Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center. |
| Placebo to IGE025 | Placebo comparator | Drug: placeboPlacebo administered subcutaneously every 4 weeks at the study center. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline
Key exclusion criteria (4 listed)
- Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact, as well as the following diseases as these diseases may have symptoms of urticaria or angioedema: Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer.
- Previous treatment with omalizumab.
- A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| IGE025Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial. | Drug | IGE025 |
| placeboStudy medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial. | Drug | Placebo to IGE025 |
Primary outcome
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Time frame: Baseline through Day 85 post-treatment
Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Time frame: Baseline through Day 85 post-treatment
Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
19 secondary outcomes
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
Time frame: Baseline through Day 85
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
Time frame: Baseline through Day 85
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit
Time frame: Baseline to Day 85
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit
Time frame: Baseline through Day 85
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.
Time frame: Baseline through Day 85
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.
Time frame: Baseline through Day 85
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set
Time frame: Baseline
Serum Levels of Omalizumab
Time frame: Baseline through Day 85
Mean (SD) Serum Total IgE Concentration From Baseline by Visit
Time frame: Baseline through Day 85
Mean (SD) Serum Total IgE % Change From Baseline by Visit
Time frame: Baseline through Day 85
Mean (SD) Serum Free IgE Concentration From Baseline by Visit
Time frame: Baseline through Day 85
Mean (SD) Serum Free IgE % Change From Baseline by Visit
Time frame: Baseline through Day 85
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit
Time frame: Baseline through Day 140
Change From Baseline in Urticaria Activity Score (UAS7)
Time frame: Baseline, Day 85
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment
Time frame: Baseline, Day 85
Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment
Time frame: Day 29 to Day 85
Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment
Time frame: Baseline through Day 85
Skindex-29 by Treatment
Time frame: Baseline and Day 85
Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment
Time frame: Baseline and Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29974963Metz M, Torene R, Kaiser S, Beste MT, Staubach P, Bauer A, Brehler R, Gericke J, Letzkus M, Hartmann N, Erpenbeck VJ, Maurer M. Omalizumab normalizes the gene expression signature of lesional skin in patients with chronic spontaneous urticaria: A randomized, double-blind, placebo-controlled study. Allergy. 2019 Jan;74(1):141-151. doi: 10.1111/all.13547. Epub 2018 Oct 15.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 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 IGE025 in people with Chronic Idiopathic Urticaria, run by Novartis Pharmaceuticals at 4 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 1 inclusion and 4 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 Nov 2014). 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?
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin (time frame: Baseline through Day 85 post-treatment). The study lists 2 primary outcomes in all. 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 NCT01599637, 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 31 Mar 2015.