A Study to Evaluate the Safety and Tolerability, and the Efficacy of Si-544 in Adults With Psoriasis Vulgaris or Psoriatic Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Men and women aged ≥18 to 75 years. 3. Willing and able to adhere to the protocol requirements. 4. Women of childbearing potential must: 1. have a negative pregnancy test (blood) at Screening and a negative pregnancy test (urine) at Day 1. 2. 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. Reliable methods for this study are: i. 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). c. agree to abstain from breast feeding during the study participation and for 90 days after the last IMP injection. 5. Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy) 6. 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:

7. Diagnosis of Ps at least 3 months before Screening. 8. 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. ≥1 tender joint out of 68 assessed joints, and. 2. ≥1 swollen joint out of 66 assessed joints (dactylitis of a digit counts as one joint each), and. 3. negative results for rheumatoid factor and anti-cyclic citrullinated peptide antibodies.

Exclusion Criteria:

1. Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP. 2. Uncontrolled hypertension or uncontrolled diabetes, as judged by the investigator. 3. 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) 4. History of seizures. 5. Presence or history of paresthesia or neuropathy. 6. Clinically significant ECG abnormalities, as judged by the investigator. 7. 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. 8. Presence of acute infection within 7 days before Screening or Day 1, as judged by the investigator. 9. Known or active infection with Mycobacterium tuberculosis and/or positive tuberculosis interferon γ release assay result at Screening. 10. Known or active infection with HIV, hepatitis B virus, or hepatitis C virus. 11. Known or suspected abuse of alcohol, drugs, or medicinal products. 12. Treatment with biologics within 1 year before Day 1. 13. UV phototherapy or systemic therapy (except methotrexate for the treatment of PsA) within 4 weeks of Day 1. 14. Vaccination within 2 weeks (for live vaccines within 4 weeks) before Day 1 and/or planned vaccination during the treatment period. 15. Current or previous (within 4 weeks before Day 1) participation in another clinical study with an IMP or a medical device. 16. Employee of the sponsor, or employee, or relative of the investigator. 17. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 18. Legal incapacity or limited legal capacity. Ps-specific

exclusion criteria:

19. Drug-induced psoriasis. PsA-specific

exclusion criteria:

19. Late stage PsA with deformed joints

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06191042
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

selectION Therapeutics GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andreas Klostermann, Dr.
Principal Investigator Affiliation selectION Therapeutics GmbH
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris, Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: si-544

Placebo Comparator: Placebo

Interventions

Drug: - si-544

Subcutaneous injection in the abdomen

Drug: - Placebo

Subcutaneous injection in the abdomen

Contact a Trial Team

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International Sites

selectION Clinical Trial Site, Bad Bentheim, Germany

Status

Recruiting

Address

selectION Clinical Trial Site

Bad Bentheim, ,

selectION Clinical Trial Site, Berlin, Germany

Status

Recruiting

Address

selectION Clinical Trial Site

Berlin, ,

selectION Clinical Trial Site, Hamburg, Germany

Status

Recruiting

Address

selectION Clinical Trial Site

Hamburg, ,

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