Bullous PemphigoidPhase 2PB-USTENCT04117932
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
A Phase 2 study testing Ustekinumab in people with Bullous Pemphigoid, run by CHU de Reims at 1 site in France.
Trial summary
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 22 Jun 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with bullous pemphigoid
- patient aged between 18 and 90
- patient with Karnofsky Performance score > 60%
- patient agreed to participate to the study
Who cannot join
- patient with allergy to corticosteroids
- patient with allergy to ustekinumab
- patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus
- malignancy < 5 years prior to inclusion
- pregnant or nursing (lactating) women, or women of child-bearing potential
- active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion
- history or presence of infection with hepatitis B or C.
- history or presence of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Trial locations and contacts
1 site in 1 country.
About this study
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.
BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.
Read more
Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.
Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.
Read the detailed description
The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid
- Conditions
- Bullous Pemphigoid
- Being tested
- Ustekinumab
- Keywords
- bullous pemphigoid, ustekinumab, superpotent topical corticosteroids, efficacy, safety
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Ustekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Arm "ustekinumab" | Experimental | Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission
Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start11 Mar 2020
- Primary completion22 Dec 2022
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117932
- Sponsor's protocol ID
- PO19083
- Acronym
- PB-USTE
- Status last verified
- Mar 2022
- First submitted
- 4 Oct 2019
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT04117932
- Acronym / sponsor ID
- PB-USTE / PO19083
- Conditions
- Bullous Pemphigoid
- Keywords
- bullous pemphigoid, ustekinumab, superpotent topical corticosteroids, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 7 Oct 2019 (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.
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.
BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.
Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.
Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.
Detailed description
The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm "ustekinumab" | Experimental | Drug: UstekinumabPatients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with bullous pemphigoid
- patient aged between 18 and 90
- patient with Karnofsky Performance score > 60%
- patient agreed to participate to the study
Key exclusion criteria (8 listed)
- patient with allergy to corticosteroids
- patient with allergy to ustekinumab
- patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus
- malignancy < 5 years prior to inclusion
- pregnant or nursing (lactating) women, or women of child-bearing potential
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 |
|---|---|---|
| UstekinumabUstekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks). | Drug | Arm "ustekinumab" |
Primary outcome
complete remission
Time frame: 28 weeks
Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)
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 8 Aug 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 2 study testing Ustekinumab in people with Bullous Pemphigoid, run by CHU de Reims at 1 site in France.
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 4 inclusion and 8 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 8 Aug 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 France. 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 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?
complete remission (time frame: 28 weeks). 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 8 Aug 2023.