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

selectION Therapeutics GmbH1 site in 1 country45 target enrollmentJanuary 22, 2024

ConditionsPsoriasis Vulgaris Psoriatic Arthritis

Interventionssi-544 Placebo

Drugssi-544 Placebo

Overview

Phase: Phase 1
Intervention: si-544
Conditions: Psoriasis Vulgaris
Sponsor: selectION Therapeutics GmbH
Enrollment: 45
Locations: 1
Primary Endpoint: Determination of safety and tolerability of treatment with si-544
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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. Likewise, the effect of si-544 on inflammatory responses in the body triggered by the disease and other disease symptoms will be investigated.

Registry

clinicaltrials.gov

Start Date

January 22, 2024

End Date

June 23, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

selectION Therapeutics GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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
•Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy, or bilateral oophorectomy)

Exclusion Criteria

•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
•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

Arms & Interventions

si-544

Intervention: si-544

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

Determination of the plasma concentrations of free si-544(Day 1 (Baseline) and Day 25)
Determination of the efficacy of si-544 treatment as assessed by psoriasis area and severity index (PASI) response rate(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 body surface area (BSA)(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)(From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16)
Determination of the pharmacodynamics (PD) of si-544 as assessed by the number of T cells in peripheral blood(From Day 1 (Baseline) to 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(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)(From Day 1 (Baseline) to Day 15, 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(From Day 1 (Baseline) to Day 29 (Week 5), Week 8, Week 12 and Week 16)
Determination of the immunogenicity of si-544 treatment(From Day 1 (Baseline) to Day 29 (Week 5) and Week 16)
Determination of the pharmacodynamics (PD) of si-544 as assessed by serum cytokine levels(From Day 1 (Baseline) to 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)(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)(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)(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)(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)(From Day 1 (Baseline) to Day 15, Day 29 (Week 5), Week 8, Week 12 and Week 16)