Bullous PemphigoidPhase 2NCT01571895
Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid
A Phase 2 study testing DF2156A in people with Bullous Pemphigoid, run by Dompé Farmaceutici S.p.A at 4 sites in 2 countries.
Trial summary
The objective of this clinical trial was to evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering bullous pemphigoid (BP) to warrant its further development. The safety of DF2156A in the specific clinical setting was also evaluated. 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?
- DF2156A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Feb 2012to 5 Jul 2012
- 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 and female patients aged >50 years.
- Patients with newly diagnosed or relapsing bullous pemphigoid based on clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin (or BP180 and/or BP230 ELISA). Confirmation by laboratory tests will be obtained ideally before or anyway within one week after enrolment.
- For the purpose of this study, clinical relapses are defined as re-appearance of clinical symptoms after the patient had attained remission lasting for more than 3 months without immunosuppressive treatment. In patients with relapsing BP, clinical diagnosis will be confirmed by indirect immunofluorescence or BP180 and/or BP230 ELISA only.
- Patients with mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions.
- Patients with modified ABSIS score ≤50
- Patients free from any systemic treatments that may affect the course of the disease with the following off-period prior to enrolment:
Show all 12Show fewer
- 3 weeks: steroids, dapsone, tetracyclines, nicotinamide,
- 3 months: azathioprine, mycofenolate mofetil, cyclophosphamide, methotrexate, intravenous immunoglobulins, immunoadsorption, TNF antagonists
- 12 months: rituximab, leflunomide
- Patients free from any topical treatments other than topical antibiotics and antiseptics in the 4 days prior to enrolment.
- Patients able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
- Patients able to provide informed consent.
Who cannot join
- Patients with a Karnofsky rating score <40%.
- Patients with mucosal involvement.
- Patients with moderate to severe renal impairment as per calculated creatinine clearance (CLcr) < 50 mL/min according to the Cockcroft-Gault formula (Cockcroft-Gault , 1976).
- Patients with hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L].
- Patients with hypoalbuminemia defined as serum albumin < 3 g/dL.
- Patients with a baseline (day 0/1, pre-dose) QTcF > 470 msec.
Show all 21Show fewer
- Patients who had a myocardial infarction in the 6 months prior to enrolment.
- Patients on treatment with phenytoin, warfarin, sulphonylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (> 50 mg/day).
- Patients with known hypersensitivity to non-steroidal antiinflammatory drugs.
- Patients using any investigational agent within 12 months prior to enrolment.
- Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males).
- Additional Exclusion Criteria for Germany only:
- Patients with hypokalemia defined as serum potassium < 3.5 mmol/L.
- Patients with clinically relevant bradycardia (heart rate < 50 beats/min)
- Patients with a complete left bundle branch block.
- Patients with a history of uncontrolled or labile hypertension
- Patients with a history of congestive heart failure.
- Patients with a history of cardiomyopathy.
- Patients with unstable angina pectoris.
- Patients with a personal or family history of congenital or documented acquired QT interval prolongation.
- Patients with a significant atrial or ventricular arrhythmia or symptomatic arrhythmia in the past.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Department of Dermatology - Universitäts-Hautklinik; Hauptstraße 7
Freiburg im Breisgau, 79104
Klinik für Dermatologie, Allergologie und Venerologie - Universitätsklinikum Schleswig-Holstein, Campus Lübeck; Ratzeburger Allee 160
Lübeck, 23538
Klinik für Dermatologie und Allergologie - Philips Universität; 35037
Marburg, 35037
Italy1 site
I Divisione di Dermatologia, Istituto Dermopatico dell'Immacolata, IRCCS;
Roma, 00167
About this study
Official title: A Phase 2, Multicentre, Single Arm, Pilot Study to Assess the Efficacy and the Safety of 150 mg Twice a Day Oral DF2156A in Patients With Active Bullous Pemphigoid.
The objective of this clinical trial was to evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering bullous pemphigoid (BP) to warrant its further development. The safety of DF2156A in the specific clinical setting was also evaluated.
Read the detailed description
The study was a phase 2, multicentre, single arm, pilot study. It has been designed to determine if DF2156A has sufficient activity to warrant its further development.
A total of twelve (12) BP patients were planned to be involved. They were planned to receive DF2156A orally at the dose of 150 mg twice a day for a maximum of 14 days.
Recruitment was intended to be competitive among the study sites, until the planned number of patients is enrolled. Competitive recruitment has been chosen to increase the speed of recruitment and to account for any unexpected occurrence at a site that negatively impact enrolment rate.
The single arm design has been chosen as an appropriate tool for this pilot phase 2 study, considering that BP is a rare disease where a placebo control is not acceptable. Moreover, as there is no spontaneous acute recovery from the active blistering condition, any improvement in patient outcome can be attributed to a positive effect of the Investigational Product.
Each patient was intended to be involved in the study for a screening period, for 14 days of treatment, for all required measurements up to hospital discharge (planned on day 8+1 of treatment) and for one assessment occasion on day 15+1, either during hospital stay or after hospital discharge (out-patient visit). An optional post-treatment visit might be scheduled at day 30+3.
Due to the lack of efficacy observed at 1/3 of the enrollment at the investigated dosage, the patients' enrollment was interrupted and trial, hence, was early terminated. More precisely, only 1 of the 4 enrolled patients completed the study's 14-day treatment period. The remaining 3 patients were discontinued from the study early (1 patient due to treatment failure and 2 patients who were discontinued and admitted to rescue therapy).
While DF2156A appeared to be safe and was generally well-tolerated with only mild AEs reported in 3 patients (and no deaths, SAEs, or discontinuations from the study due to AEs), the limited sample size of the safety population prevents any overall conclusions of safety regarding the investigational product. For this reason no results other than listings are available.
See the MEX0111 synopsis on the EU Clinical Trial Register: https://www.clinicaltrialsregister.eu/ctr-search/rest/download/result/attachment/2011-000756-42/1/27931
- Conditions
- Bullous Pemphigoid
- Being tested
- DF2156A
- Keywords
- Autoimmune inflammatory blistering disorder
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF2156ADrug
DF2156A is a novel small molecule that inhibits the biological activity of the CXC ligand 8 [CXCL8; formerly interleukin (IL)-8] through inhibition of the activation of CXCL8 receptors: CXCR1 and CXCR2. This specific inhibitor stems from a program of drug design of molecules intended to modulate chemokine action.
| Study group | Role | What they receive |
|---|---|---|
| DF2156A 150 mg | Experimental | 150 mg capsule twice a day (every 12 h) for a maximum of 14 days Receives: Drug: DF2156A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of blisters from baseline
Total number of blisters from baseline
Measured: day 0/1 (pre-dose), 8 and 15
Modified ABSIS score change from baseline
ABSIS score will be measured according to the pemphigus scoring sheet [Rosenbach, 2009] adjusted to the clinical manifestation in BP patients, as per specifications in protocol.
Measured: day 0/1 (pre-dose), 8 and 15
Physician Global Assessment (PGA) score measured on a 0-10 scale [Rosenbach, 2009]. Percent change from baseline
PGA score will be measured according to the following scale:
0
1 2 3 4 5 6 7 8 9 10 Perfect Worst health skin condition imaginable
The following guidelines will help standardize PGA:
0: no lesions 2: almost cleared, no functional impairment 4: few lesions / low functional impairment 6: moderate 8: severe / extensive 10: life-threatening
Measured: day 0/1 (pre-dose), 8 and 15
Pruritus measured on a 10 cm visual analogue scale. Absolute value change from baseline
Pruritus will be measured according to the following scale:
0 10 No pruritus Worst pruritus I can imagine
Measured: day 0/1 (pre-dose), 8 and 15
Eosinophil blood count. Percent change from baseline
Eosinophil blood count. Percent change from baseline
Measured: screening and day 15
Percentage of patients with treatment failure (drug discontinuation due to disease worsening)
treatment failure (drug discontinuation due to disease worsening)
Measured: day 8
Percentage of patients completely free from blisters
Percentage of patients completely free from blisters
Measured: day 15
Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional
Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional
Measured: Day 30
QTcF. Change from baseline
QTcF. Change from baseline
Measured: Italy: day 0/1 (pre-dose), day 1, 5, 8 and 15___Ger:day 0/1 (pre-dose), day 1, 3, 5, 8 and 15
Incidence of Adverse Events and Serious Adverse Events
Incidence of Adverse Events and Serious Adverse Events
Measured: throughout the study up to day 15 or 30
Blisters percent change from baseline
Blisters percent change from baseline
Measured: day 0/1 (pre-dose), 8 and 15
Modified ABSIS score percent change from baseline
ABSIS score will be measured according to the pemphigus scoring sheet [Rosenbach, 2009] adjusted to the clinical manifestation in BP patients, as per specifications in protocol.
Measured: day 0/1 (pre-dose), 8 and 15
Physician Global Assessment (PGA) score measured on a 0-10 scale [Rosenbach, 2009]. Absolute value change from baseline
PGA score will be measured according to the following scale:
0
1 2 3 4 5 6 7 8 9 10 Perfect Worst health skin condition imaginable
The following guidelines will help standardize PGA:
0: no lesions 2: almost cleared, no functional impairment 4: few lesions / low functional impairment 6: moderate 8: severe / extensive 10: life-threatening
Measured: day 0/1 (pre-dose), 8 and 15
Pruritus measured on a 10 cm visual analogue scale. Percent change from baseline
Pruritus will be measured according to the following scale:
0 10 No pruritus Worst pruritus I can imagine
Measured: day 0/1 (pre-dose), 8 and 15
Eosinophil blood count. Absolute number change from baseline
Eosinophil blood count. Absolute number change from baseline
Measured: screening and day 15
Number of patients with treatment failure (drug discontinuation due to disease worsening)
Number of patients with treatment failure (drug discontinuation due to diseas
Measured: day 8
Number of patients completely free from blisters
Number of patients completely free from blisters
Measured: day 15
QTcF. Absolute value
QTcF. Absolute value
Measured: Italy: day 0/1 (pre-dose), day 1, 5, 8 and 15___Ger:day 0/1 (pre-dose), day 1, 3, 5, 8 and 15
Secondary outcomes (1)
Plasma levels of DF2156A and its major metabolites (DF2227 and DF2108) at steady state conditions
Plasma levels of DF2156A and its major metabolites (DF2227 and DF2108) at steady state conditions
Measured: day 5 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study start20 Feb 2012
- Primary completion5 Jul 2012
- Study completion5 Jul 2012
Why it stopped: Lack of efficacy observed at 1/3 of the enrollment at investigated dosage. No results available.
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.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biagio Didona, MD, Principal investigator, I Divisione di Dermatologia, Istituto Dermopatico dell'Immacolata, IRCCS; 00167 Roma, ItalyDetlef Zillikens, MD, Principal investigator, Klinik für Dermatologie, Allergologie und Venerologie - Univ. Schleswig-Holstein; Lübeck, GermanyAndrea Kneisel, MD, Principal investigator, Klinik für Dermatologie und Allergologie - Philips Universität; 35037 Marburg, GermanyJohannes Kern, MD, Principal investigator, Department of Dermatology - Universitäts-Hautklinik; 79104 Freiburg, GermanyPier Adelchi Ruffini, MD, Study director, Development Director Dompé s.p.a., 20122 Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571895
- Sponsor's protocol ID
- MEX0111
- Other IDs
- 2011-000756-42
- Status last verified
- Dec 2023
- First submitted
- 4 Apr 2012
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicentre, Single Arm, Pilot Study to Assess the Efficacy and the Safety of 150 mg Twice a Day Oral DF2156A in Patients With Active Bullous Pemphigoid.
- ClinicalTrials.gov ID
- NCT01571895
- Acronym / sponsor ID
- MEX0111
- Conditions
- Bullous Pemphigoid
- Keywords
- Autoimmune inflammatory blistering disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy observed at 1/3 of the enrollment at investigated dosage. No results available.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2012 (actual)
- Primary completion
- 5 Jul 2012 (actual)
- Study completion
- 5 Jul 2012 (actual)
- First posted
- 5 Apr 2012 (estimated)
- 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 objective of this clinical trial was to evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering bullous pemphigoid (BP) to warrant its further development. The safety of DF2156A in the specific clinical setting was also evaluated.
Detailed description
The study was a phase 2, multicentre, single arm, pilot study. It has been designed to determine if DF2156A has sufficient activity to warrant its further development.
A total of twelve (12) BP patients were planned to be involved. They were planned to receive DF2156A orally at the dose of 150 mg twice a day for a maximum of 14 days.
Recruitment was intended to be competitive among the study sites, until the planned number of patients is enrolled. Competitive recruitment has been chosen to increase the speed of recruitment and to account for any unexpected occurrence at a site that negatively impact enrolment rate.
The single arm design has been chosen as an appropriate tool for this pilot phase 2 study, considering that BP is a rare disease where a placebo control is not acceptable. Moreover, as there is no spontaneous acute recovery from the active blistering condition, any improvement in patient outcome can be attributed to a positive effect of the Investigational Product.
Each patient was intended to be involved in the study for a screening period, for 14 days of treatment, for all required measurements up to hospital discharge (planned on day 8+1 of treatment) and for one assessment occasion on day 15+1, either during hospital stay or after hospital discharge (out-patient visit). An optional post-treatment visit might be scheduled at day 30+3.
Due to the lack of efficacy observed at 1/3 of the enrollment at the investigated dosage, the patients' enrollment was interrupted and trial, hence, was early terminated. More precisely, only 1 of the 4 enrolled patients completed the study's 14-day treatment period. The remaining 3 patients were discontinued from the study early (1 patient due to treatment failure and 2 patients who were discontinued and admitted to rescue therapy).
While DF2156A appeared to be safe and was generally well-tolerated with only mild AEs reported in 3 patients (and no deaths, SAEs, or discontinuations from the study due to AEs), the limited sample size of the safety population prevents any overall conclusions of safety regarding the investigational product. For this reason no results other than listings are available.
See the MEX0111 synopsis on the EU Clinical Trial Register: https://www.clinicaltrialsregister.eu/ctr-search/rest/download/result/attachment/2011-000756-42/1/27931
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DF2156A 150 mg | Experimental | Drug: DF2156A150 mg capsule twice a day (every 12 h) for a maximum of 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female patients aged >50 years.
- Patients with newly diagnosed or relapsing bullous pemphigoid based on clinical diagnosis to be confirmed by direct immunofluorescence and indirect immunofluorescence on salt-spit skin (or BP180 and/or BP230 ELISA). Confirmation by laboratory tests will be obtained ideally before or anyway within one week after enrolment.
- For the purpose of this study, clinical relapses are defined as re-appearance of clinical symptoms after the patient had attained remission lasting for more than 3 months without immunosuppressive treatment. In patients with relapsing BP, clinical diagnosis will be confirmed by indirect immunofluorescence or BP180 and/or BP230 ELISA only.
- Patients with mild to moderate active blistering disease (total number of blisters between 1 and 30) whether associated or not with urticarial/eczematous lesions.
- Patients with modified ABSIS score ≤50
Key exclusion criteria (21 listed)
- Patients with a Karnofsky rating score <40%.
- Patients with mucosal involvement.
- Patients with moderate to severe renal impairment as per calculated creatinine clearance (CLcr) < 50 mL/min according to the Cockcroft-Gault formula (Cockcroft-Gault , 1976).
- Patients with hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L].
- Patients with hypoalbuminemia defined as serum albumin < 3 g/dL.
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 |
|---|---|---|
| DF2156ADF2156A is a novel small molecule that inhibits the biological activity of the CXC ligand 8 [CXCL8; formerly interleukin (IL)-8] through inhibition of the activation of CXCL8 receptors: CXCR1 and CXCR2. This specific inhibitor stems from a program of drug design of molecules intended to modulate chemokine action. | Drug | DF2156A 150 mg |
Primary outcome
Total number of blisters from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
Total number of blisters from baseline
Modified ABSIS score change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
ABSIS score will be measured according to the pemphigus scoring sheet [Rosenbach, 2009] adjusted to the clinical manifestation in BP patients, as per specifications in protocol.
Physician Global Assessment (PGA) score measured on a 0-10 scale [Rosenbach, 2009]. Percent change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
PGA score will be measured according to the following scale: 0 1 2 3 4 5 6 7 8 9 10 Perfect Worst health skin condition imaginable The following guidelines will help standardize PGA: 0: no lesions 2: almost cleared, no functional impairment 4: few lesions / low functional impairment 6: moderate 8: severe / extensive 10: life-threatening
Pruritus measured on a 10 cm visual analogue scale. Absolute value change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
Pruritus will be measured according to the following scale: 0 10 No pruritus Worst pruritus I can imagine
Eosinophil blood count. Percent change from baseline
Time frame: screening and day 15
Eosinophil blood count. Percent change from baseline
Percentage of patients with treatment failure (drug discontinuation due to disease worsening)
Time frame: day 8
treatment failure (drug discontinuation due to disease worsening)
Percentage of patients completely free from blisters
Time frame: day 15
Percentage of patients completely free from blisters
Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional
Time frame: Day 30
Number of patients who are still free from blisters without requiring any systemic or topical rescue treatment - Optional
QTcF. Change from baseline
Time frame: Italy: day 0/1 (pre-dose), day 1, 5, 8 and 15___Ger:day 0/1 (pre-dose), day 1, 3, 5, 8 and 15
QTcF. Change from baseline
Incidence of Adverse Events and Serious Adverse Events
Time frame: throughout the study up to day 15 or 30
Incidence of Adverse Events and Serious Adverse Events
Blisters percent change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
Blisters percent change from baseline
Modified ABSIS score percent change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
ABSIS score will be measured according to the pemphigus scoring sheet [Rosenbach, 2009] adjusted to the clinical manifestation in BP patients, as per specifications in protocol.
Physician Global Assessment (PGA) score measured on a 0-10 scale [Rosenbach, 2009]. Absolute value change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
PGA score will be measured according to the following scale: 0 1 2 3 4 5 6 7 8 9 10 Perfect Worst health skin condition imaginable The following guidelines will help standardize PGA: 0: no lesions 2: almost cleared, no functional impairment 4: few lesions / low functional impairment 6: moderate 8: severe / extensive 10: life-threatening
Pruritus measured on a 10 cm visual analogue scale. Percent change from baseline
Time frame: day 0/1 (pre-dose), 8 and 15
Pruritus will be measured according to the following scale: 0 10 No pruritus Worst pruritus I can imagine
Eosinophil blood count. Absolute number change from baseline
Time frame: screening and day 15
Eosinophil blood count. Absolute number change from baseline
Number of patients with treatment failure (drug discontinuation due to disease worsening)
Time frame: day 8
Number of patients with treatment failure (drug discontinuation due to diseas
Number of patients completely free from blisters
Time frame: day 15
Number of patients completely free from blisters
QTcF. Absolute value
Time frame: Italy: day 0/1 (pre-dose), day 1, 5, 8 and 15___Ger:day 0/1 (pre-dose), day 1, 3, 5, 8 and 15
QTcF. Absolute value
1 secondary outcome
Plasma levels of DF2156A and its major metabolites (DF2227 and DF2108) at steady state conditions
Time frame: day 5 and 8
Results and safety
The study was stopped early (reason given: Lack of efficacy observed at 1/3 of the enrollment at investigated dosage. No results available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 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.
Biagio Didona, MD principal investigator
I Divisione di Dermatologia, Istituto Dermopatico dell'Immacolata, IRCCS; 00167 Roma, Italy
Detlef Zillikens, MD principal investigator
Klinik für Dermatologie, Allergologie und Venerologie - Univ. Schleswig-Holstein; Lübeck, Germany
Andrea Kneisel, MD principal investigator
Klinik für Dermatologie und Allergologie - Philips Universität; 35037 Marburg, Germany
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DF2156A in people with Bullous Pemphigoid, run by Dompé Farmaceutici S.p.A at 4 sites in 2 countries.
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 21 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: stopped early, as of the sponsor's last update on 22 Dec 2023. 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, Italy. 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 was stopped early (reason given: Lack of efficacy observed at 1/3 of the enrollment at investigated dosage. No results available.). Results are not available in the source record.
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?
Total number of blisters from baseline (time frame: day 0/1 (pre-dose), 8 and 15). The study lists 18 primary outcomes in all. 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 22 Dec 2023.