Bullous PemphigoidPhase 2IPHNCT04563923
Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody
A Phase 2 study testing Avdoralimab (IPH5401) in people with Bullous Pemphigoid, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
The development of Auto Immune bullous Diseases (AIBD) results from a complex interaction between innate and adaptive immune systems. Bullous pemphigoid (BP), the most frequently encountered AIBD, predominantly affects elderly patients above 70 with an estimated incidence of 21.7 new cases/million/year in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Avdoralimab (IPH5401)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Oct 2020to 31 Mar 2024
- 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
- Male or female
- ≥ 18 years of age at the time of signing the informed consent document
- Clinical diagnosis of BP confirmed by histology, immunohistochemistry and/or ELISA data
- Patient requiring a treatment by superpotent topical steroids
- Patients hospitalized for the treatment of their BP
- For female, only post-menopaused patients
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- For male patients included in the study with partners of child bearing potential should agree to use highly effective contraception for the duration of the study and 6 months after the last dose of avdoralimab
- Signed informed consent document prior to any study related assessments/procedures being conducted
- Patient able to adhere to the study visit schedule and other protocol requirements
- Patient registered to the French Social Security
Who cannot join
- Patients requiring systemic steroids according to the physician in charge
- Contra indication to topical steroid
- Use of systemic steroids or any immunosuppressive drugs in the past 4 weeks
- Use of doxycycline or minocycline in the past 4 weeks
- Use of systemic rituximab or omalizumab or dupilimumab in the past 12 weeks
- Use of intravenous immunoglobulmins (IVIG) in the past 4 weeks
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- Impossibility to come every week to receive the injection
- Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
- Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom
Trial locations and contacts
4 sites in 1 country.
France4 sites
APHM, Timone
Marseille, Bouche Du Rhône, 13005
APHM, Hôpital Nord
Marseille, Bouches du rhône, 13000
CHU Montpellier, Dermatologie
Montpellier, Herault, 34005
CHU de Nice- Dermatologie
Nice, Alpes-Maritimes, 06200
About this study
The development of Auto Immune bullous Diseases (AIBD) results from a complex interaction between innate and adaptive immune systems. Bullous pemphigoid (BP), the most frequently encountered AIBD, predominantly affects elderly patients above 70 with an estimated incidence of 21.7 new cases/million/year in France.Interestingly, coversin, an anti-C5a and -leukotriene B4 small molecule, is currently used in a phase IIA clinical trial in BP patients (NCT04035733). However, although overall C5-blocking drugs are potentially interesting, they are likely to interfere with C5a-C5aR2-axis activation as well, a pathway that has recently proved protective in BP 12. The main objective is to investigate the clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids compared to superpotent topical steroids alone in BP patients at 3 months.It is a case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier university hospitals) specialized in the in the care of BP patients will be participating in the study. It is expected that forty subjects will be included in this trial.
Conversely, a more targeted inhibition of C5a-C5aR1 axis might be more effective in BP, sparing the potentially protective effect of C5a-C5aR2 interaction.
Avdoralimab (IPH5401), a specific anti-C5aR1 monoclonal antibody, has already been credited of a good safety profile in the treatment of solid tumors and rheumatoid arthritis. The investigators hypothesize that avdoralimab might be a safe and effective treatment in BP patients
- Conditions
- Bullous Pemphigoid
- Being tested
- Avdoralimab (IPH5401), Control
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avdoralimab (IPH5401)Drug
Preparation of avdoralimab and preparation of the syringes are to be performed aseptically by site pharmacy qualified personnel.
ControlOther
Superpotent topical steroids are the gold standard treatment for BP. All patients will receive 0.05% Clobetasol propionate cream as follows:
- Patients of less than 45kg of body weight: 2 tubes of 10g/d
- Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesion
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Patients in this group will additionally receive 3 s.c. injections of avdoralimab every week during 12 weeks
They receive 0.05% Clobetasol propionate cream as follows:
* Patients of less than 45kg of body weight: 2 tubes of 10g/d
* Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesions Receives: Drug: Avdoralimab (IPH5401) |
| Conventional therapy | Other | Superpotent topical steroids are the gold standard treatment for BP. All patients will receive 0.05% Clobetasol propionate cream as follows:
* Patients of less than 45kg of body weight: 2 tubes of 10g/d
* Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesions Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clinical Remission
To investigate the clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids compared to superpotent topical steroids alone in BP patients.The efficacy will be evaluated through the proportion of patients in complete clinical remission (CCR) at 3 months without any relapse during the study period. The CCR will be defined as the absence of new bullous and skin inflammatory lesions and absence of pruritus for at least 2 weeks.
Measured: At 3 Months
Secondary outcomes (2)
The delay
To compare between the treatment groups the delay to complete clinical remission (CCR)
Measured: At 3 months
Initial Clinical Remission
To compare between the treatment groups the delay to initial clinical remission (ICR)
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start10 Oct 2020
- Primary completion30 Apr 2023
- Study completion31 Mar 2024
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 Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- It is a case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier university hospitals) specialized in the in the care of BP patients will be participating in the study. It is expected that forty subjects will be included in this trial.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, CHU de Nice, Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563923
- Sponsor's protocol ID
- 20-PP-13
- Acronym
- IPH
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Passeron T, Fontas E, Boye T, Richard MA, Delaporte E, Dereure O. Treatment of Bullous Pemphigoid with Avdoralimab: Multicenter, Randomized, Open-Labeled Phase 2 Study. JID Innov. 2024 Aug 23;4(6):100307. doi: 10.1016/j.xjidi.2024.100307. eCollection 2024 Nov.
PubMed 39310808
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT04563923
- Acronym / sponsor ID
- IPH / 20-PP-13
- Conditions
- Bullous Pemphigoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 25 Sep 2020 (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 development of Auto Immune bullous Diseases (AIBD) results from a complex interaction between innate and adaptive immune systems. Bullous pemphigoid (BP), the most frequently encountered AIBD, predominantly affects elderly patients above 70 with an estimated incidence of 21.7 new cases/million/year in France.Interestingly, coversin, an anti-C5a and -leukotriene B4 small molecule, is currently used in a phase IIA clinical trial in BP patients (NCT04035733). However, although overall C5-blocking drugs are potentially interesting, they are likely to interfere with C5a-C5aR2-axis activation as well, a pathway that has recently proved protective in BP 12. The main objective is to investigate the clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids compared to superpotent topical steroids alone in BP patients at 3 months.It is a case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier university hospitals) specialized in the in the care of BP patients will be participating in the study. It is expected that forty subjects will be included in this trial.
Conversely, a more targeted inhibition of C5a-C5aR1 axis might be more effective in BP, sparing the potentially protective effect of C5a-C5aR2 interaction.
Avdoralimab (IPH5401), a specific anti-C5aR1 monoclonal antibody, has already been credited of a good safety profile in the treatment of solid tumors and rheumatoid arthritis. The investigators hypothesize that avdoralimab might be a safe and effective treatment in BP patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a case-controlled, randomized, open-labelled, and multicenter phase II clinical trial. Four Dermatologic French centers (Nice, Marseille Nord, Marseille Timone and Montpellier university hospitals) specialized in the in the care of BP patients will be participating in the study. It is expected that forty subjects will be included in this trial.
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Avdoralimab (IPH5401)Patients in this group will additionally receive 3 s.c. injections of avdoralimab every week during 12 weeks They receive 0.05% Clobetasol propionate cream as follows: * Patients of less than 45kg of body weight: 2 tubes of 10g/d * Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesions |
| Conventional therapy | Other | Other: ControlSuperpotent topical steroids are the gold standard treatment for BP. All patients will receive 0.05% Clobetasol propionate cream as follows: * Patients of less than 45kg of body weight: 2 tubes of 10g/d * Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- ≥ 18 years of age at the time of signing the informed consent document
- Clinical diagnosis of BP confirmed by histology, immunohistochemistry and/or ELISA data
- Patient requiring a treatment by superpotent topical steroids
- Patients hospitalized for the treatment of their BP
Key exclusion criteria (9 listed)
- Patients requiring systemic steroids according to the physician in charge
- Contra indication to topical steroid
- Use of systemic steroids or any immunosuppressive drugs in the past 4 weeks
- Use of doxycycline or minocycline in the past 4 weeks
- Use of systemic rituximab or omalizumab or dupilimumab in the past 12 weeks
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 |
|---|---|---|
| Avdoralimab (IPH5401)Preparation of avdoralimab and preparation of the syringes are to be performed aseptically by site pharmacy qualified personnel. | Drug | Drug |
| ControlSuperpotent topical steroids are the gold standard treatment for BP. All patients will receive 0.05% Clobetasol propionate cream as follows: * Patients of less than 45kg of body weight: 2 tubes of 10g/d * Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesion | Other | Conventional therapy |
Primary outcome
Complete Clinical Remission
Time frame: At 3 Months
To investigate the clinical efficacy of an anti-C5aR1 antibody in addition to superpotent topical steroids compared to superpotent topical steroids alone in BP patients.The efficacy will be evaluated through the proportion of patients in complete clinical remission (CCR) at 3 months without any relapse during the study period. The CCR will be defined as the absence of new bullous and skin inflammatory lesions and absence of pruritus for at least 2 weeks.
2 secondary outcomes
The delay
Time frame: At 3 months
Initial Clinical Remission
Time frame: At 3 months
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 24 Mar 2026.
- Results publication: PubMed 39310808Passeron T, Fontas E, Boye T, Richard MA, Delaporte E, Dereure O. Treatment of Bullous Pemphigoid with Avdoralimab: Multicenter, Randomized, Open-Labeled Phase 2 Study. JID Innov. 2024 Aug 23;4(6):100307. doi: 10.1016/j.xjidi.2024.100307. eCollection 2024 Nov.
- Individual participant dataSharing planned: Undecided
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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.
Passeron Thierry, PhD principal investigator
CHU de Nice, Dermatologie
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 Avdoralimab (IPH5401) in people with Bullous Pemphigoid, run by Centre Hospitalier Universitaire de Nice at 4 sites 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 10 inclusion and 9 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 24 Mar 2026. 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 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 Clinical Remission (time frame: At 3 Months). 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 NCT04563923, 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 24 Mar 2026.