Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis

NCT05916365 | Active Not Recruiting Phase 3

• 2 other identifiers: M-17923-322022-502575-30-00
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 32

Brief Summary

The main purpose of the study is to assess the long-term tolerability and effectiveness of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD). Participants who complete the last assessment visit in ADjoin (Week 100) will be offered the opportunity to enroll in this extension study.

Conditions

Atopic Dermatitis

Keywords

Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)

  Baseline up to Week 110

Secondary Outcomes (9)

• Percentage of Participants with Eczema Area and Severity Index (EASI) 50, EASI 75, and EASI 90 (>=50%, >=75%, and >=90%) Reduction in EASI Scores

  Baseline up to Week 108

• Percentage Change from Baseline of Parent study in EASI Score

  Baseline up to Week 108

• Percentage of Participants with EASI Score <=7

  Baseline up to Week 108

• Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1

  Baseline up to Week 108

• Percentage of Participants Achieving Pruritus Numeric Rating Score (NRS) <= 4

  Baseline up to Week 108

Other Outcomes (1)

• Number of Participants with TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

  Baseline up to Week 110

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

Adult and adolescent participants (12 to less than \[\<\] 18 years and weighing greater than or equal to \[\>=\] 40 kilogram \[kg\]) with moderate-to-severe AD will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection via pre-filled syringe (PFS) for every fourth week (Q4W) for up to Week 104. If participants response is below EASI50 at any visit, lebrikizumab dosing frequency may be increased to every two weeks (Q2W) at any time during the course of the study; thereafter, lebrikizumab Q4W dosing may be resumed at the Investigator's discretion. Lebrikizumab will be administered up to Week 106 for participants who continue Q2W dosing, and these participants will undergo a safety follow-up assessment at Week 110.

Biological: Lebrikizumab

Interventions

Lebrikizumab BIOLOGICAL

Lebrikizumab solution for injection administered subcutaneously

Lebrikizumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study.
• For WOCBP: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab.
• NOTE: A WOCBP is defined as a postmenarcheal female, who has not reached a postmenopausal state (\>=12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus).
• NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, vasectomized partner, or sexual abstinence. In the context of this protocol, sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
• Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent/assent in accordance with institutional and regulatory guidelines.
• Capable of giving signed informed consent/assent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Participants who, having participated in ADjoin, had their last lebrikizumab dose administered in a window longer than 8 weeks prior to the Baseline Visit in the current study.
• Participants who, during their participation in the parent trial or ADjoin, developed an SAE or a severe AE that was deemed related to lebrikizumab, which in the opinion of the Investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
• Conditions in the parent study or ADjoin consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.).
• Treatment with a live (attenuated) vaccine from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study.
• Use of a prohibited medication from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study.
• Pregnant or breastfeeding women, and women planning to become pregnant or breastfeed during the study and for at least 4 weeks after the last dose of lebrikizumab.
• Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the participant's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make participant's participation unreliable, or may interfere with study assessments.
• Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial.
• Participant who is an employee or relative of an employee at the research site or Almirall.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (32)

Investigator Site 7

Darmstadt, Hesse, 64283, Germany

Location

Investigator Site 8

Frankfurt am Main, Hesse, 60590, Germany

Location

Investigator Site 10

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Investigator Site 9

Osnabrück, Lower Saxony, 49074, Germany

Location

Investigator Site 11

Münster, North Rhine-Westphalia, 48149, Germany

Location

Investigator Site 12

Leipzig, Saxony, 04103, Germany

Location

Investigator Site 1

Augsburg, 86150, Germany

Location

Investigator Site 2

Berlin, 10789, Germany

Location

Investigator Site 3

Berlin, 13055, Germany

Location

Investigator Site 4

Dresden, D-01307, Germany

Location

Investigator Site 5

Hamburg, 20144, Germany

Location

Investigator Site 6

Hamburg, 20537, Germany

Location

Investigator Site 26

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Investigator Site 25

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

Investigator Site 23

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

Location

Investigator Site 28

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Investigator Site 27

Warsaw, Masovian Voivodeship, 02-625, Poland

Location

Investigator Site 31

Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440, Poland

Location

Investigator Site 32

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Investigator Site 29

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Investigator Site 30

Gdansk, Woj. Pomorskie, 80-344, Poland

Location

Investigator Site 13

Gdansk, 80-462, Poland

Location

Investigator Site 14

Katowice, 40-600, Poland

Location

Investigator Site 15

Kielce, 25-155, Poland

Location

Investigator Site 16

Lublin, 20-081, Poland

Location

Investigator Site 17

Poznan, 60-214, Poland

Location

Investigator Site 18

Rzeszów, 35-055, Poland

Location

Investigator Site 19

Szczecin, 71-434, Poland

Location

Investigator Site 20

Tarnów, 33-100, Poland

Location

Investigator Site 21

Warsaw, 01-142, Poland

Location

Investigator Site 22

Wroclaw, 50-566, Poland

Location

Investigator Site 24

Lodz, Łódź Voivodeship, 90-436, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Aleksandra Stjepanovic

  Almirall, S.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 23, 2023
• Study Start: May 23, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

DE (12); PL (20)