Hidradenitis SuppurativaPhase 1NCT03972280
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
A Phase 1 study testing Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody in people with Hidradenitis Suppurativa and Palmoplantar Pustulosis, run by CSL Behring at 11 sites in 3 countries.
Trial summary
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa, Palmoplantar Pustulosis
- What is being tested?
- Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 4 Jul 2019to 4 Oct 2022
- Phase
- Phase 1
- 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
- Male or female subjects between 18 and 75 years of age, inclusive
- Confirmed clinical diagnosis of moderate to severe HS as per International Hidradenitis Suppurativa Severity Score System (IHS4) guidelines (ie, IHS4 ≥ 4)
- PPP differentiated from other forms of pustulosis
- Psoriasis with a Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) score of ≥ 12.
- Subjects with HS only: inadequate response to at least a 3-month (90 days) trial of oral antibiotics for treatment of HS
- Subjects with PPP only: confirmed clinical diagnosis of PPP at least 6 months before Screening and inadequate response to topical therapy, phototherapy, and / or previous systemic therapy for the treatment of PPP
Who cannot join
- Treatment with any medications and therapies not permitted during the study.
- History of myeloproliferative disease.
- Malignancy within 5 years at Screening with the exception of nonmelanoma skin cancer, carcinoma in situ, or prostate cancer not requiring treatment.
- Current, or a recent clinically significant history of, uncontrolled renal, hepatic(including currently active hepatitis B virus and / or hepatitis C virus), hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as potentially having an effect on study outcomes as determined by the Investigator and / or Sponsor.
- Congenital or acquired immunosuppressive condition(s), including human immunodeficiency virus infection.
- Clinical signs of active infection and / or fever > 38°C during the 7 days before Day 1.
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- Clinically significant abnormalities on physical examination, ECG, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L) at Screening.
- Subjects with PPP only: concurrent psoriasis vulgaris (not including scaly scalp and / or ears).
- Subjects with HS only: > 20 draining fistulas."
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Australia4 sites
Holdsworth House Medical Practice
Darlinghurst, 2010
Fremantle Dermatology
Fremantle, 6160
The Royal Melbourne Hospital
Parkville, 3052
Westmead Hospital
Westmead, 2145
Germany4 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
St. Josef Hospital
Bochum, 44791
Klinikum Darmstadt
Darmstadt, 64283
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Denmark3 sites
Bispebjerg Hospital
Copenhagen, 2400
Gentofte Hospital
Hellerup, 2900
Zealand University Hospital
Roskilde, 4000
About this study
Official title: A Multicenter, Open-label, 2-regimen, Repeat-dose Study to Assess the Safety and Pharmacokinetics of Intravenous CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.
- Conditions
- Hidradenitis Suppurativa, Palmoplantar Pustulosis
- Being tested
- Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
- Medical subject headings
- Hidradenitis Suppurativa, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyBiological
Also called CSL324
Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (HS) | Experimental | Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS Receives: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
| Dose Level 1 (PPP) | Experimental | Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP Receives: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
| Dose Level 1 (Total) | Experimental | Dose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP Receives: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
| Dose Level 2 (HS) | Experimental | Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS Receives: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
| Dose Level 2 (PPP) | Experimental | Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP Receives: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
| Dose Level 2 (Total) | Experimental | Dose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP Receives: Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 24 weeks
TEAEs by severity
Measured: Up to 24 weeks
TEAEs by casuality
Measured: Up to 24 weeks
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
Measured: Up to 24 weeks
AESIs: Grade 3 and 4 neutropenia by causality
Measured: Up to 24 weeks
Incidence of AESIs: Grade 3 and 4 infection
Measured: Up to 24 weeks
AESIs: Grade 3 and 4 infection by causality
Measured: Up to 24 weeks
Secondary outcomes (12)
Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
Measured: Up to 22 days after dose
Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered
Measured: Up to 22 days after dose
Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered
Measured: Up to 22 days after dose
Cmax of CSL324 in serum for the last dose administered
Measured: Up to 22 days after dose
Tmax of CSL324 in serum for the last dose administered
Measured: Up to 84 days after dose
AUCtau of CSL324 in serum for the last dose administered
Measured: Up to 22 days after dose
Half life (t½) of CSL324 in serum for the last dose administered
Measured: Up to 84 days after dose
Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered
Measured: Up to 22 days after dose
Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered
Measured: Up to 22 days after dose
Ctrough of CSL324 for each dose of CSL324 administered
Measured: Up to 22 days after each dose
Accumulation ratio for AUCtau (ratio between AUCtau of the last dose and of the first dose) and accumulation ratio for Cmax (ratio between Cmax of the last dose and of the first dose)
Measured: Up to 22 days after each dose
Presence of anti-CSL324 antibodies in serum
Measured: Up to 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start4 Jul 2019
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972280
- Sponsor's protocol ID
- CSL324_1002
- Other IDs
- 2018-002871-17, 2018
- Status last verified
- May 2023
- First submitted
- 31 May 2019
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, 2-regimen, Repeat-dose Study to Assess the Safety and Pharmacokinetics of Intravenous CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
- ClinicalTrials.gov ID
- NCT03972280
- Acronym / sponsor ID
- CSL324_1002
- Conditions
- Hidradenitis Suppurativa, Palmoplantar Pustulosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 3 Jun 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.
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 (HS) | Experimental | Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyDose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS |
| Dose Level 1 (PPP) | Experimental | Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyDose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP |
| Dose Level 1 (Total) | Experimental | Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyDose 1 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP |
| Dose Level 2 (HS) | Experimental | Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyDose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS |
| Dose Level 2 (PPP) | Experimental | Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyDose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with PPP |
| Dose Level 2 (Total) | Experimental | Biological: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyDose 2 of recombinant anti-G-CSF receptor monoclonal antibody administered intravenously to subjects with HS or PPP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects between 18 and 75 years of age, inclusive
- Confirmed clinical diagnosis of moderate to severe HS as per International Hidradenitis Suppurativa Severity Score System (IHS4) guidelines (ie, IHS4 ≥ 4)
- PPP differentiated from other forms of pustulosis
- Psoriasis with a Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) score of ≥ 12.
- Subjects with HS only: inadequate response to at least a 3-month (90 days) trial of oral antibiotics for treatment of HS
Key exclusion criteria (9 listed)
- Treatment with any medications and therapies not permitted during the study.
- History of myeloproliferative disease.
- Malignancy within 5 years at Screening with the exception of nonmelanoma skin cancer, carcinoma in situ, or prostate cancer not requiring treatment.
- Current, or a recent clinically significant history of, uncontrolled renal, hepatic(including currently active hepatitis B virus and / or hepatitis C virus), hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as potentially having an effect on study outcomes as determined by the Investigator and / or Sponsor.
- Congenital or acquired immunosuppressive condition(s), including human immunodeficiency virus infection.
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 |
|---|---|---|
| Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibodyAlso: CSL324Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion | Biological | Dose Level 1 (HS), Dose Level 1 (PPP), Dose Level 1 (Total), Dose Level 2 (HS), Dose Level 2 (PPP), Dose Level 2 (Total) |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 24 weeks
TEAEs by severity
Time frame: Up to 24 weeks
TEAEs by casuality
Time frame: Up to 24 weeks
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
Time frame: Up to 24 weeks
AESIs: Grade 3 and 4 neutropenia by causality
Time frame: Up to 24 weeks
Incidence of AESIs: Grade 3 and 4 infection
Time frame: Up to 24 weeks
AESIs: Grade 3 and 4 infection by causality
Time frame: Up to 24 weeks
12 secondary outcomes
Maximum concentration (Cmax) of CSL324 in serum for the first dose administered
Time frame: Up to 22 days after dose
Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered
Time frame: Up to 22 days after dose
Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered
Time frame: Up to 22 days after dose
Cmax of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Tmax of CSL324 in serum for the last dose administered
Time frame: Up to 84 days after dose
AUCtau of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Half life (t½) of CSL324 in serum for the last dose administered
Time frame: Up to 84 days after dose
Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered
Time frame: Up to 22 days after dose
Ctrough of CSL324 for each dose of CSL324 administered
Time frame: Up to 22 days after each dose
Accumulation ratio for AUCtau (ratio between AUCtau of the last dose and of the first dose) and accumulation ratio for Cmax (ratio between Cmax of the last dose and of the first dose)
Time frame: Up to 22 days after each dose
Presence of anti-CSL324 antibodies in serum
Time frame: Up to 168 days
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 26 May 2023.
- Individual participant dataSharing planned: Yes. CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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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.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody in people with Hidradenitis Suppurativa and Palmoplantar Pustulosis, run by CSL Behring at 11 sites in 3 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 6 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, Germany, Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to 24 weeks). The study lists 7 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 26 May 2023.