Chronic Spontaneous UrticariaPhase 2DUPICSUNCT03749135
Dupilumab in Chronic Spontaneous Urticaria
A Phase 2 study testing Dupilumab in people with Chronic Spontaneous Urticaria and Recurrent Angioedema, run by Charite University, Berlin, Germany at 6 sites in Germany.
Trial summary
The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria, Recurrent Angioedema
- What is being tested?
- Dupilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 6 sitesGermany
- Study dates
- 12 Nov 2018to 7 Jul 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: chronic spontaneous urticaria (defined as ongoing disease)
- Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- Male or Female
- Patient is 18-75 years of age
- Patient is diagnosed with moderate to severe CSU and refractory to standard of care treatment at the time of randomization, as defined by the following:
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- The presence of itch and hives for more than 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine
- Urticaria activity score UAS7 score (range 0-42) equal or more than 16, 7 days prior to randomization (Day 1)
- CSU diagnosis for 6 months
- Willing and able to complete a daily symptom diary for the duration of the study and adhere to the study visit schedules.
- Patients must not have more than one missing diary entry in the 7 days prior to randomization. Re-screening may be considered.
- Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study.
Who cannot join
- Patients whose urticaria is solely due to inducible urticaria.
- Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
- Any other active skin disease associated with chronic itching that might confound the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, etc.)
- Patients who have received concomitant prohibited medication within the last 3 months prior to screening
- Anti-IgE therapy (e.g. omalizumab)
- Routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids or other immunosuppressants
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- Intravenous immunoglobulins
- Biological therapy
- Systemic immunosuppressants
- Live/attenuated vaccines
- Other investigational drug
- History of anaphylactic shock
- Active helminthic parasite infection or treatment of helminthic parasites within 6 months of screening
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Charite University, Berlin, Germany
Berlin, 10117
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Universitätsmedizin Leipzig, Klinik für Dermatologie, Venerologie und Allergologie
Leipzig, Saxony, 04103
Hautklinik der Universitätsmedizin Mainz Clinical Research Center
Mainz, Rheinland-Pfalz, Germany, 55101
Universitätsklinikum Giessen und Marburg
Marburg, Hesse, 35043
Hautklinik Universitätsklinikum Münster
Münster, NRW, Germany, 48149
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Phase 2, 16-week Treatment Study With a 16 Week Follow-up Period to Assess the Efficacy and Safety of Dupilumab (Anti-IL4Ra) in Adult Patients With Chronic Spontaneous Urticaria Despite H1-antihistamine Treatment.
The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment.
Read the detailed description
Treatment with Dupilumab has been shown to reduce clinically significant exacerbations and to improve skin symptom control as well as quality of life in moderate to severe atopic dermatitis patients and in moderate to severe asthma patients. It has been approval by European Medicines Agency (EMA) for the treatment of atopic dermatitis patients in September 2017.
Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and was previously found to be effective in atopic dermatitis and asthma. Considering that CSU and atopic diseases share many common features (e.g. key pathogenic role of mast cells and immunoglobulin E (IgE), itch is a dominant symptom, Th2 dominance), it is reasonable to expect that Dupilumab is beneficial in CSU.
These results suggest that Dupilumab may provide an effective treatment option for patients with insufficient treatment responses to H1-antihistamines exhibiting wheal and flare type skin reactions.
The gold standard treatment of CSU consists of administration of antihistamines. In more than 50% of the patients, symptoms persist with standard dosing of antihistamines. In antihistamine-refractory patients with chronic spontaneous urticaria, the currently only licensed treatment is omalizumab, a monoclonal anti-IgE antibody. In 2014, omalizumab has been licensed for add-on therapy in CSU patients who still have symptoms despite standard-dosed antihistamine treatment. There is, however, still a great medical need for additional treatment options, as 20-40% of patients are still without effective therapy. These patients have no other licensed treatment option and can only be treated off-label with therapeutics with several known safety risks such as Cyclosporine A.
Dupilumab has excellent potential to provide symptom control in CSU. This study will provide additional valuable insights into the therapeutic potential of Dupilumab in improving quality of life in these patients, in addition to managing CSU symptoms.
- Being tested
- Dupilumab, Placebo
- Keywords
- hives, itch
- Medical subject headings
- Chronic Urticaria, Angioedema, Urticaria, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
anti-IL4-Receptor alpha
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Active comparator | Dupilumab (anti-IL4Ra), s.c. administration Receives: Drug: Dupilumab |
| Placebo Comparator | Placebo comparator | matching Placebo, s.c. administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urticaria activity score over 7 days (UAS7)
0-42 Points total range over 7 days, higher values equal more disease activity
Measured: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)
Secondary outcomes (6)
Itch severity score (ISS7; 0 - no pruritus; 21 - most severe pruritus), hive severity score (HSS7; 0 - no hives; 21 - max. hive severity)
Disease activity scores
Measured: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)
Global assessment for disease activity
Global assessment for disease activity(physician and patient) by visual analogue scale (VAS; 0 - no pain; 10 - max. amount of pain)
Measured: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)
urticaria control test (UCT; 16 - complete disease control; 0 - strong symptoms), dermatological quality of life (DLQI; 0 - no impairment; 30 - max. impairment), chronic urticaria quality of life (Cu2-QoL; 23 - no impairment; 115 - max. impairment)
Disease specific quality of life
Measured: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)
Responder rates (regarding disease activity and quality of live (QoL))
Responder rates (regarding disease activity and quality of live (QoL))
Measured: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)
rate of angioedema burdened days angioedema activity score (AAS; 0 - lowest disease activity; 15 - highest disease activity) angioedema quality of life (AE-Qol; 0 - no impairment; 100 - worst impairment)
For patients with concomitant angioedema
Measured: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]
Rescue medication use
Frequency of of how often rescue medication is used
Measured: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start12 Nov 2018
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
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.
- 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
- Model description
- This is a Phase 2a multicenter, randomized, double blind, placebo controlled, parallel group, two-arm, proof-of-concept investigator-initiated trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Proinnovera GmbH
- Responsible party
- Principal investigator, Marcus Maurer, Charite University, Berlin, Germany
- Investigators
- Marcus Maurer, Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749135
- Sponsor's protocol ID
- D-001-01
- Other IDs
- 2017-004458-41, 2017
- Acronym
- DUPICSU
- Status last verified
- Feb 2022
- First submitted
- 12 Jul 2018
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Phase 2, 16-week Treatment Study With a 16 Week Follow-up Period to Assess the Efficacy and Safety of Dupilumab (Anti-IL4Ra) in Adult Patients With Chronic Spontaneous Urticaria Despite H1-antihistamine Treatment.
- ClinicalTrials.gov ID
- NCT03749135
- Acronym / sponsor ID
- DUPICSU / D-001-01
- Keywords
- hives, itch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Sanofi, Proinnovera GmbH
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 21 Nov 2018 (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.
The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria (CSU) who are symptomatic despite H1-antihistamine treatment.
Detailed description
Treatment with Dupilumab has been shown to reduce clinically significant exacerbations and to improve skin symptom control as well as quality of life in moderate to severe atopic dermatitis patients and in moderate to severe asthma patients. It has been approval by European Medicines Agency (EMA) for the treatment of atopic dermatitis patients in September 2017.
Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and was previously found to be effective in atopic dermatitis and asthma. Considering that CSU and atopic diseases share many common features (e.g. key pathogenic role of mast cells and immunoglobulin E (IgE), itch is a dominant symptom, Th2 dominance), it is reasonable to expect that Dupilumab is beneficial in CSU.
These results suggest that Dupilumab may provide an effective treatment option for patients with insufficient treatment responses to H1-antihistamines exhibiting wheal and flare type skin reactions.
The gold standard treatment of CSU consists of administration of antihistamines. In more than 50% of the patients, symptoms persist with standard dosing of antihistamines. In antihistamine-refractory patients with chronic spontaneous urticaria, the currently only licensed treatment is omalizumab, a monoclonal anti-IgE antibody. In 2014, omalizumab has been licensed for add-on therapy in CSU patients who still have symptoms despite standard-dosed antihistamine treatment. There is, however, still a great medical need for additional treatment options, as 20-40% of patients are still without effective therapy. These patients have no other licensed treatment option and can only be treated off-label with therapeutics with several known safety risks such as Cyclosporine A.
Dupilumab has excellent potential to provide symptom control in CSU. This study will provide additional valuable insights into the therapeutic potential of Dupilumab in improving quality of life in these patients, in addition to managing CSU symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a Phase 2a multicenter, randomized, double blind, placebo controlled, parallel group, two-arm, proof-of-concept investigator-initiated trial
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Active comparator | Drug: DupilumabDupilumab (anti-IL4Ra), s.c. administration |
| Placebo Comparator | Placebo comparator | Drug: Placebomatching Placebo, s.c. administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis: chronic spontaneous urticaria (defined as ongoing disease)
- Patient is informed about study procedures and medications and has given written informed consent before any assessment.
- Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
- Male or Female
- Patient is 18-75 years of age
Key exclusion criteria (13 listed)
- Patients whose urticaria is solely due to inducible urticaria.
- Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
- Any other active skin disease associated with chronic itching that might confound the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, etc.)
- Patients who have received concomitant prohibited medication within the last 3 months prior to screening
- History of anaphylactic shock
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 |
|---|---|---|
| Dupilumabanti-IL4-Receptor alpha | Drug | Dupilumab |
| PlaceboPlacebo | Drug | Placebo Comparator |
Primary outcome
Urticaria activity score over 7 days (UAS7)
Time frame: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)
0-42 Points total range over 7 days, higher values equal more disease activity
6 secondary outcomes
Itch severity score (ISS7; 0 - no pruritus; 21 - most severe pruritus), hive severity score (HSS7; 0 - no hives; 21 - max. hive severity)
Time frame: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)
Global assessment for disease activity
Time frame: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)
urticaria control test (UCT; 16 - complete disease control; 0 - strong symptoms), dermatological quality of life (DLQI; 0 - no impairment; 30 - max. impairment), chronic urticaria quality of life (Cu2-QoL; 23 - no impairment; 115 - max. impairment)
Time frame: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)
Responder rates (regarding disease activity and quality of live (QoL))
Time frame: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)
rate of angioedema burdened days angioedema activity score (AAS; 0 - lowest disease activity; 15 - highest disease activity) angioedema quality of life (AE-Qol; 0 - no impairment; 100 - worst impairment)
Time frame: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]
Rescue medication use
Time frame: Change from 7 days prior to baseline (V1) to 7 days prior to week 16 (V9)]
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 2 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Marcus Maurer, Prof. principal investigator
Charite University, Berlin, Germany
6 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 Dupilumab in people with Chronic Spontaneous Urticaria and Recurrent Angioedema, run by Charite University, Berlin, Germany at 6 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 12 inclusion and 13 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 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Urticaria activity score over 7 days (UAS7) (time frame: Change from 7 days prior to baseline (Visit (V) 1) to 7 days prior to week 16 (V9)). 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 2 Feb 2022.