A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants

NCT04444466 | Terminated Phase 1

• 2 other identifiers: UP00862019-002981-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral UCB8600.

Conditions

Healthy Study Participants; Chronic Spontaneous Urticaria

Keywords

Healthy study participants; UCB8600; Phase 1; Chronic spontaneous urticaria; CSU; IgE; Atopic participants; Urticaria; UCB; Food Effect (Part D)

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event is characterized according to the intake of the study medication.

  From Baseline (Day 1) until the End of Study (up to Day 42)

Secondary Outcomes (8)

• The maximum plasma concentration (Cmax) of a single dose UCB8600

  Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose

• Time to maximum plasma concentration (tmax) of a single dose UCB8600

  Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose

• The area under the curve (AUC) of a single dose UCB8600

  Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose

• The maximum plasma concentration (Cmax) of multiple doses UCB8600

  Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose

• Time to maximum plasma concentration (tmax) of multiple doses UCB8600

  Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose

Study Arms (2)

UCB8600

EXPERIMENTAL

Study participants randomized to this arm will receive various single doses and multiple doses of UCB8600 administered to various cohorts.

Drug: UCB8600

Placebo

PLACEBO COMPARATOR

Study participants randomized to this arm will receive various single doses and multiple doses of Placebo administered to various cohorts.

Other: Placebo

Interventions

UCB8600 DRUG

Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period.

UCB8600

Placebo OTHER

Study participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600.

Also known as: PBO

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Applicable to Parts A-D
• Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent
• Participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests at the Screening Visit
• Body weight 45 kg or greater and body mass index (BMI) within the range 19 and 30 kg/m\^2 (inclusive)
• Part B-specific
• Study participants must be documented to be sensitized to at least 1 common aeroallergen confirmed by (skin prick test (SPT) at Screening)
• Part C-specific
• Study participants must have a diagnosis of chronic spontaneous urticaria (CSU) diagnosed by a dermatologist, allergist or clinical immunologist and have persistent symptoms most days of the week for the last 6 weeks despite regular use of an H1 antihistamine according to the EAACI/GA²LEN/EDF/WAO guideline
• Study participants must have a documented 7-day Urticaria Assessment Score (UAS7) score of 16 or above and an 7-day Itch Severity Score (ISS7) of 8 or above at Visit 2 (Day -1, Admission)
• Study participants must have a Screening serum immunoglobulin E (IgE) of ≥30 kU/L

You may not qualify if:

• Applicable to Parts A-D
• Participant has any (acute or chronic \[including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\]) medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
• Study participant has 12-lead electrocardiogram (ECG) with changes considered to be clinically significant (eg, QT interval corrected using Fridericia's formula (QTcF) \>450 msec , left bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or Day -1 (Admission)
• A history of additional risk factors for Torsades de pointes (TdP) (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
• Study participant has a history of atopy, allergic rhinitis, urticaria, angioedema, asthma, food allergies, or anaphylaxis
• Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
• Study participant has a history of drug allergy or other allergy that, in the opinion of the investigator or UCB Study Physician, contraindicates his/her participation
• Study participants with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All participants will be screened at Screening. If stool testing is positive for pathogenic organism, the participants will not enter Treatment Period and will not be allowed to rescreen
• Study participant has received prescription or nonprescription medicines (including over-the-counter medicines and herbal and dietary supplements \[including St John's Wort\]) that have been taken within 14 days prior to Screening. Drugs that are strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 and/or P-glycoprotein (Pgp) are prohibited
• The use of concomitant medications that prolong the QT/QTc interval
• Study participant has donated more than 500 mL of blood or blood products within 90 days prior to Admission (Day -1) or plans to donate blood during the study (20 weeks post Screening)
• Study participant has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of UCB8600
• Part B-specific
• Study participant has:
• a history of angioedema, severe asthma, severe food allergies, or anaphylaxis

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0086 001

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an investigator- and participant-blind study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort design

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 30, 2020
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)