Psoriasis VulgarisPhase 1NCT06191042
A Study to Evaluate the Safety and Tolerability, and the Efficacy of Si-544 in Adults With Psoriasis Vulgaris or Psoriatic Arthritis
A Phase 1 study testing si-544 in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by selectION Therapeutics GmbH at 4 sites in Germany.
Trial summary
The main objective of this study is to investigate the safety and tolerability of si-544. Other objectives are to study the metabolism of si-544 in the body and to assess the effects of si-544 on cells of the body's immune system (immune cells) that have been chronically activated by the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris, Psoriatic Arthritis
- What is being tested?
- si-544
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesGermany
- Study dates
- 22 Jan 2024to 23 Jun 2025
- 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
- Subject has the capacity for consenting, was informed about the nature, the scope, and the relevance of the clinical study, voluntarily agrees in participation and in the study provisions, and duly signed the ICF approved by the ethics committee before any study-related procedure is performed
- Men and women aged ≥18 to 75 years
- Willing and able to adhere to the protocol requirements
- Women of childbearing potential must:
- have a negative pregnancy test (blood) at Screening and a negative pregnancy test (urine) at Day 1
- agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, from Screening through 30 days after the last IMP injection
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- Reliable methods for this study are:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) iii. intrauterine device iv. intrauterine hormone-releasing system v. bilateral tubal occlusion vi. vasectomized sexual partner (provided that the partner is the sole sexual partner of the woman of childbearing potential and has received medical assessment of the surgical success) vii. sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) Abstinence is only accepted as true abstinence: when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods and withdrawal] is not an acceptable method of contraception).
- agree to abstain from breast feeding during the study participation and for 90 days after the last IMP injection
- Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy)
- Men must agree to practice true abstinence or to use a condom during sexual contact with a pregnant woman or a woman of childbearing potential during study participation and for at least 90 days after the last IMP injection, even after undergoing a successful vasectomy.
- Ps-specific inclusion criteria:
- Diagnosis of Ps at least 3 months before Screening
- Active Ps with ≥3% BSA involved and with at least 1 psoriatic plaque (other than nail change)
- PsA-specific inclusion criteria:
- 7. Diagnosis of PsA based on the classification for psoriatic arthritis criteria (CASPAR) at least 3 months before Screening
- 8. Diagnosis of active Ps with at least 1 psoriatic plaque (other than nail change)
- 9. Active PsA defined as
- ≥1 tender joint out of 68 assessed joints, and
- ≥1 swollen joint out of 66 assessed joints (dactylitis of a digit counts as one joint each), and
- negative results for rheumatoid factor and anti-cyclic citrullinated peptide antibodies
Who cannot join
- Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP
- Uncontrolled hypertension or uncontrolled diabetes, as judged by the investigator
- Chronic disease other than Ps or PsA not adequately controlled by stable treatment (ie, no changes or initiation of treatment within 4 weeks before Screening and Day 1)
- History of seizures
- Presence or history of paresthesia or neuropathy
- Clinically significant ECG abnormalities, as judged by the investigator
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- Clinically relevant disease which could affect the safety of the subject during the study or impede the subject's ability to complete the study, as assessed by the investigator
- Presence of acute infection within 7 days before Screening or Day 1, as judged by the investigator
- Known or active infection with Mycobacterium tuberculosis and/or positive tuberculosis interferon γ release assay result at Screening
- Known or active infection with HIV, hepatitis B virus, or hepatitis C virus
- Known or suspected abuse of alcohol, drugs, or medicinal products
- Therapy with biologics used for the treatment of Ps and/o PsA (including those under investigation) within 1 year before Day 1
- UV phototherapy or systemic therapy (except methotrexate for the treatment of PsA) within 4 weeks of Day 1
- Vaccination within 2 weeks (for live vaccines within 4 weeks) before Day 1 and/or planned vaccination during the treatment period
- Current or previous (within 4 weeks before Day 1) participation in another clinical study with an IMP or a medical device
- Employee of the sponsor, or employee, or relative of the investigator
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Legal incapacity or limited legal capacity
- Ps-specific exclusion criteria:
- Drug-induced psoriasis
- PsA-specific exclusion criteria:
- 19. Late stage PsA with deformed joints
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
selectION Clinical Trial Site
Bad Bentheim
selectION Clinical Trial Site
Berlin
selectION Clinical Trial Site
Blankenfelde-Mahlow
selectION Clinical Trial Site
Hamburg
About this study
Official title: A Multicenter, Phase 1b, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability, and the Efficacy of Si-544 in Adults With Psoriasis Vulgaris or Psoriatic Arthritis
The main objective of this study is to investigate the safety and tolerability of si-544.
Other objectives are to study the metabolism of si-544 in the body and to assess the effects of si-544 on cells of the body's immune system (immune cells) that have been chronically activated by the disease. Likewise, the effect of si-544 on inflammatory responses in the body triggered by the disease and other disease symptoms will be investigated.
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis
- Being tested
- si-544, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
si-544Drug
Subcutaneous injection in the abdomen
PlaceboDrug
Subcutaneous injection in the abdomen
| Study group | Role | What they receive |
|---|---|---|
| si-544 | Experimental | Not described Receives: Drug: si-544 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of safety and tolerability of treatment with si-544
Occurrence of adverse events (AEs) and serious AEs (SAEs), including description of type, frequency, severity, and causal relationship of adverse events (AEs) and serious AEs
Measured: From Day -35 to Day 106
Determination of safety and tolerability of treatment with si-544
Change in clinical laboratory, electrocardiogram (ECG), vital signs, and peripheral oxygen saturation from Baseline to all assessed timepoints
Measured: From Day 1 (Baseline) to Day 106
Secondary outcomes (16)
Determination of the plasma concentrations of free si-544
Plasma concentrations of free si-544
Measured: Day 1 (Baseline) and Day 25
Determination of the pharmacodynamics (PD) of si-544 as assessed by the number of T cells in peripheral blood
Change in the number of T cells in peripheral blood
Measured: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the pharmacodynamics (PD) of si-544 as assessed by immunophenotypes of T cell subsets
Change in immunophenotypes of T cell subsets
Measured: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the pharmacodynamics (PD) of si-544 as assessed by serum cytokine levels
Change in serum cytokine levels
Measured: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the immunogenicity of si-544 treatment
Change in anti-drug antibodies against si-544 in serum
Measured: From Day 1 (Baseline) to Day 29 (Week 5) and Week 16
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI)
Change in the psoriasis area and severity index (PASI)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI) response rate
Difference in psoriasis area and severity index (PASI) response rate (defined as subjects with ≥1 score improvement from Baseline)
Measured: At Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by physician's global assessment (PGA) of disease activity
Change in the physician's global assessment (PGA) of disease activity
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by body surface area (BSA)
Change in affected body surface area (BSA)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by a numeric rating scale (NRS)
Change in the mean itch using a numeric rating scale (NRS)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by a numeric rating scale (NRS)
Change in the worst itch using a numeric rating scale (NRS)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriasis vulgaris (Ps) in Ps patients only as assessed by dermatological life quality index (DLQI)
Change in the dermatological life quality index (DLQI)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assessed by psoriatic arthritis quality of life (PsAQoL)
Change in the psoriatic arthritis quality of life (PsAQoL)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only (assessment of pain)
Change in the subject's assessment of pain using a visual analog scale (VAS)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assesses by the 66 swollen joint count (SJC66)
Change in the 66 swollen joint count (SJC66)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assessed by the 68 tender joint count (TJC68)
Change in the 68 tender joint count (TJC68)
Measured: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start22 Jan 2024
- Primary completion23 Jun 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- selectION Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Andreas Klostermann, Dr., Study director, selectION Therapeutics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191042
- Sponsor's protocol ID
- SEL-002
- Other IDs
- 2023-507393-40, 2023
- Status last verified
- Jun 2025
- First submitted
- 10 Dec 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in sanctioning by EU data protection authorities. The sponsor wants to avoid this.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 1b, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability, and the Efficacy of Si-544 in Adults With Psoriasis Vulgaris or Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06191042
- Acronym / sponsor ID
- SEL-002
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- selectION Therapeutics GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 5 Jan 2024 (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 main objective of this study is to investigate the safety and tolerability of si-544.
Other objectives are to study the metabolism of si-544 in the body and to assess the effects of si-544 on cells of the body's immune system (immune cells) that have been chronically activated by the disease. Likewise, the effect of si-544 on inflammatory responses in the body triggered by the disease and other disease symptoms will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| si-544 | Experimental | Drug: si-544 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject has the capacity for consenting, was informed about the nature, the scope, and the relevance of the clinical study, voluntarily agrees in participation and in the study provisions, and duly signed the ICF approved by the ethics committee before any study-related procedure is performed
- Men and women aged ≥18 to 75 years
- Willing and able to adhere to the protocol requirements
- Women of childbearing potential must:
- Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy)
Key exclusion criteria (22 listed)
- Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP
- Uncontrolled hypertension or uncontrolled diabetes, as judged by the investigator
- Chronic disease other than Ps or PsA not adequately controlled by stable treatment (ie, no changes or initiation of treatment within 4 weeks before Screening and Day 1)
- History of seizures
- Presence or history of paresthesia or neuropathy
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 |
|---|---|---|
| si-544Subcutaneous injection in the abdomen | Drug | si-544 |
| PlaceboSubcutaneous injection in the abdomen | Drug | Placebo |
Primary outcome
Determination of safety and tolerability of treatment with si-544
Time frame: From Day -35 to Day 106
Occurrence of adverse events (AEs) and serious AEs (SAEs), including description of type, frequency, severity, and causal relationship of adverse events (AEs) and serious AEs
Determination of safety and tolerability of treatment with si-544
Time frame: From Day 1 (Baseline) to Day 106
Change in clinical laboratory, electrocardiogram (ECG), vital signs, and peripheral oxygen saturation from Baseline to all assessed timepoints
16 secondary outcomes
Determination of the plasma concentrations of free si-544
Time frame: Day 1 (Baseline) and Day 25
Determination of the pharmacodynamics (PD) of si-544 as assessed by the number of T cells in peripheral blood
Time frame: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the pharmacodynamics (PD) of si-544 as assessed by immunophenotypes of T cell subsets
Time frame: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the pharmacodynamics (PD) of si-544 as assessed by serum cytokine levels
Time frame: From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the immunogenicity of si-544 treatment
Time frame: From Day 1 (Baseline) to Day 29 (Week 5) and Week 16
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI) response rate
Time frame: At Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by physician's global assessment (PGA) of disease activity
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by body surface area (BSA)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by a numeric rating scale (NRS)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment as assessed by a numeric rating scale (NRS)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriasis vulgaris (Ps) in Ps patients only as assessed by dermatological life quality index (DLQI)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assessed by psoriatic arthritis quality of life (PsAQoL)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only (assessment of pain)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assesses by the 66 swollen joint count (SJC66)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
Determination of the efficacy of si-544 treatment on symptoms of psoriatic arthritis (PsA) in PsA patients only as assessed by the 68 tender joint count (TJC68)
Time frame: From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16
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 3 Jul 2025.
- Individual participant dataSharing planned: No. Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in sanctioning by EU data protection authorities. The sponsor wants to avoid this.
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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.
Andreas Klostermann, Dr. study director
selectION Therapeutics GmbH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing si-544 in people with Psoriasis Vulgaris and Psoriatic Arthritis, run by selectION Therapeutics GmbH at 4 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 21 inclusion and 22 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 3 Jul 2025. 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. 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 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?
Determination of safety and tolerability of treatment with si-544 (time frame: From Day -35 to Day 106). The study lists 2 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 3 Jul 2025.