A Phase 1/2A, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeat-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate the Safety, Pharmacokinetics, and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)

Status: Completed
Location: See all (16) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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⁃ Part A Healthy study participants

• Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)

• Participant must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

• Participant has a body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)

• Participant can be male or female and must agree to use contraception

⁃ Part B Participants with moderate to severe Atopic dermatitis (AtD)

• Participant must be 18 to 65 years of age inclusive at the time of signing the ICF

• Participant has moderate or severe AtD that has been present for at least 12 months prior to initiating the study (signing of the ICF) and with:

• A validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline

• An Eczema Area and Severity Index (EASI) score of ≥14 at Screening and ≥16 at Baseline

• Pruritis Numerical Rating Scale (NRS) ≥3 at Screening and Baseline

• ≥10 % body surface area (BSA) of AtD involvement at Screening and Baseline

• Either documented recent history (within 6 months before the Screening Visit) of inadequate response to treatment with topical medications (regular use of topical corticosteroids \[TCS\] or topical calcineurin inhibitors \[TCIs\]) or when topical treatments are confirmed to be otherwise medically inadvisable (eg, because of important side effects or safety risks)

• Participant has a BMI within the range 18 to 35 kg/m2 (inclusive)

Locations
United States
California
Up0110 125
Beverly Hills
Up0110 101
Glendale
Up0110 116
Los Angeles
Up0110 121
Northridge
Up0110 126
Tustin
Up0110 127
Valencia
Florida
Up0110 108
Clearwater
Up0110 109
Miami Lakes
Up0110 106
Ocala
Up0110 102
St. Petersburg
Georgia
Up0110 111
College Park
Minnesota
Up0110 114
Minneapolis
North Carolina
Up0110 124
Winston-salem
New York
Up0110 107
New York
Oklahoma
Up0110 104
Oklahoma City
Pennsylvania
Up0110 119
Philadelphia
Time Frame
Start Date: 2022-03-07
Completion Date: 2025-09-19
Participants
Target number of participants: 273
Treatments
Experimental: UCB1381 dosing regime 1 in Part A
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Experimental: UCB1381 dosing regime 2 in Part A
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Experimental: UCB1381 dosing regime 3 in Part A
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Experimental: UCB1381 dosing regime 4 in Part A
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Experimental: UCB1381 dosing regime 5 in Part A
Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).
Experimental: UCB1381 dosing regime 6 in Part A
Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).
Experimental: UCB1381 dosing regime 7 in Part A
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Experimental: UCB1381 dosing regime 8 in Part A
Participants will be randomized to receive a single dose UCB1381 intravenously (iv).
Experimental: UCB1381 dosing regime 9 in Part B
Participants will be randomized to receive repeated doses UCB1381 intravenously (iv).
Placebo_comparator: Placebo iv Arm Part A
Participants will be randomized to receive a single dose of placebo iv to maintain the blinding.
Placebo_comparator: Placebo sc Arm Part A
Participants will be randomized to receive a single dose of placebo sc to maintain the blinding.
Placebo_comparator: Placebo iv Arm Part B
Participants will be randomized to receive repeated doses of placebo iv to maintain the blinding.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov

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