A First-In-Human Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: si-544

• Registration Number: NCT05383378
• Lead Sponsor: selectION Therapeutics GmbH

Brief Summary

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Study Start: 2022-08-30
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

SAD and MAD part

1. Change (ie, starting anew, change in frequency, or change in drug substance) in standard systemic and topical therapy, or in immunosuppressive drug therapy within 4 weeks before Screening (for biologics such as dupilumab, the therapy may not be changed within 12 weeks before Screening), as judged by the investigator

2. Known history of hypersensitivity to constituents or excipients in the pharmaceutical formulation of the IMP

3. Uncontrolled hypertension or uncontrolled diabetes

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 hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease, as judged by the investigator

8. Presence of acute infection within 7 days before Screening, as judged by the investigator

9. Known or active infection with Mycobacterium tuberculosis

10. Known or active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

11. Vaccination within 2 weeks before Screening and/or planned vaccination during the SAD part or the treatment period of the MAD part

12. Pregnancy

13. Any finding or medical condition prohibiting the inclusion in the study, as judged by the investigator

14. Current or previous (within 4 weeks before Screening) participation in another clinical study with an investigational medicinal product or medical device

15. Known or suspected abuse of alcohol, drugs, or medicinal products

16. Employee of the sponsor, or employee, or relative of the investigator

17. Use of prohibited medication

18. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

19. Legal incapacity or limited legal capacity

    MAD part

20. Previous participation in the SAD part of this study with IMP dosing within 3 months before the planned first dosing of the MAD part.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo.
si-544	si-544	The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in hematology parameter hematocrit to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter hematocrit the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter mean corpuscular hemoglobin concentration to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter mean corpuscular hemoglobin concentration the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter differential leukocyte count to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter differential leukocyte count the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter hemoglobin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in aspartate aminotransferase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of aspartate aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in alanine aminotransferase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of alanine aminotransferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter erythrocytes to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter erythrocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter plateletes to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter platelets the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter leukocytes to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in gamma-glutamyl transferase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of gamma-glutamyl transferase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in total bilirubin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of total bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in conjugated (direct) bilirubin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of conjugated (direct) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter total protein to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter total protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry hemoglobin A1c to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter hemoglobin A1c the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Adverse events (AEs)	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	AEs will be summarized and tabulated according to the primary system organ class and preferred term. Separate analyses will be conducted using severity, seriousness, and relationship to the IMP.
Change from Baseline in hematology parameter mean corpuscular volume to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter mean corpuscular volume the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in hematology parameter mean corpuscular hemoglobin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of hematology parameter mean corpuscular hemoglobin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection
Change from Baseline in uric acid to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of uric acid the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in estimated glomerular filtration rate to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of estimated glomerular filtration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter inorganic phosphate to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter inorganic phosphate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter amylase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter amylase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter sodium to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter sodium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter calcium to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter calcium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter lipase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter lipase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry triglycerides to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter triglycerides the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry ferritin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter ferritin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry lactate dehydrogenase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter lactate dehydrogenase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in alkaline phosphatase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of alkaline phosphatase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in unconjugated (indirect) bilirubin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of unconjugated (indirect) bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood urea nitrogen to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood urea nitrogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in creatinine to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of creatinine the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter potassium to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter potassium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter magnesium to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter magnesium the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter creatine phosphokinase to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter creatine phosphokinase the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter glucose (non-fasting) to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter glucose (non-fasting) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry D-dimer to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter D-dimer the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter chloride to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter chloride the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry parameter albumin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter albumin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood coagulation parameter international normalized ratio (INR) all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood coagulation parameter international normalized ratio (INR) the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter nitrites to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter nitrites the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in heart rate to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of heart rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in respiration rate to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of respiration rate the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter blood to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter blood the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter protein to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in 12-lead ECG parameter QRS-interval to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of 12-lead ECG parameter QRS-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in 12-lead ECG parameter QTc[F]-interval to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of 12-lead ECG parameter QTc\[F\]-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood pressure to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood pressure the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in body temperature to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of body temperature the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry cholesterol to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter cholesterol the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter glucose to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter glucose the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter ketones to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter ketones the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in 12-lead ECG parameter QT-interval to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of 12-lead ECG parameter QT-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood biochemistry C-reative protein to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood biochemistry parameter C-reactive protein the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood coagulation partial thromboplastin time to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood coagulation parameter partial thromboplastin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in blood coagulation parameter prothrombin time to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of blood coagulation parameter prothrombin time the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter bilirubin to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter bilirubin the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in peripheral oxygen saturation to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of peripheral oxygen saturation the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter pH to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter pH the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter leukocytes to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter leukocytes the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in urinalysis parameter urobilinogen to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of urinalysis parameter urobilinogen the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.
Change from Baseline in 12-lead ECG parameter PR-interval to all assessments during the study	MAD part: Between Day 1 (first IMP injection) and Day 106 (last visit)	For the analyses of 12-lead ECG parameter PR-interval the absolute values, and changes from Baseline will be summarized for all assessed time points. Baseline is defined as the last assessment before IMP injection.

Secondary Outcome Measures

Name	Time	Method
MAD part: Change from Baseline in immunophenotyping of T-cell subsets at Day 29, and Weeks 8, 12, and 16	Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)	Blood sampling window on Day 1: up to 15 minutes before IMP injection.
SAD part: Plasma concentration of free si-544 in blood plasma at Day 1	Day 1	Blood collections up to 15 minutes before, and immediately, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours after IMP injection. The sampling window will be ±1 minute for ≤1 hour, ±5 minutes for 2 hours, ±15 minutes for 4 hours, and ±30 minutes for 8 hours post injection.; Plasma concentration of free si-544 in blood plasma will be analyzed by descriptive statistics by treatment group.
MAD part: Plasma concentration of free si-544 in blood plasma at Days 1 and 25	Day 1 and Day 25	Blood collections up to 15 minutes before, and immediately, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours after IMP injection. The sampling window will be ±1 minute for ≤1 hour, ±5 minutes for 2 hours, ±15 minutes for 4 hours, and ±30 minutes for 8 hours post injection.; Plasma concentration of free si-544 in blood plasma will be analyzed by descriptive statistics by treatment group and visit.
MAD part: Change from Baseline in serum cytokine levels at Day 29, and Weeks 8, 12, and 16	Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)	Blood sampling window on Day 1: up to 15 minutes before IMP injection.
Change from Baseline in anti-drug antibodies against si-544 in serum at Day 29	Day 1 and Day 29	Blood sampling window on Day 1: up to 15 minutes before IMP injection.
Change from Baseline in inflamed areas using the body surface area index at Days 15 and 29, and Weeks 8, 12, and 16	Day 1, Day 15, Day 29, Week 8, Week 12, and Week 16 (last visit)	The body surface index will be used to assess the inflamed skin areas as percentage of the total body surface area (BSA). Percentage of BSA affected by AD with each body part accounted for by: head and neck: 9%, upper limbs: 9% each, lower limbs: 18% each, anterior trunk: 18%, back: 18%, and genitals: 1%. The score for each affected area is added up with the total possible (ie, all areas affected) score for being 100 (ie, 100% of BSA).
MAD part: Change from Baseline in number of T cells in peripheral blood at Day 29, and Weeks 8, 12, and 16	Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)	Blood sampling window on Day 1: up to 15 minutes before IMP injection.
Change from Baseline in atopic dermatitis (AD) severity by SCOring AD (SCORAD) at Days 15 and 29, and Weeks 8, 12, and 16	Day 1, Day 15, Day 29, Week 8, Week 12, and Week 16 (last visit)	The AD severity assessment will be done by SCORing Atopic Dermatitis (SCORAD). SCORAD is a composite score of 3 components: (A) the BSA involved in AD, (B) the severity of 6 clinical signs, and (C) a subject-reported component assessing pruritus and sleep loss. The total score is calculated with a maximal total score of 103. A score \<25 indicates mild, score 25-60 moderate, and score 61-103 severe AD.
MAD part: Optional: Change from Baseline of expression levels of Kv1.3 vs KCa3.1 of effector memory T cells at Day 29, and Weeks 8, 12, and 16	Day 1, Day 29, Week 8, Week 12, and Week 16 (last visit)	Blood sampling window on Day 1: up to 15 minutes before IMP injection.

Trial Locations

Locations (1)

selectION Clinical Trial Site; 🇩🇪 Wuppertal, Germany