Clinical trial NCT05916365: Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis
Official title: A 2-year Open-label Extension Study to Assess the Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Dermatitis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study.
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.).
4. 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.
5. 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.
6. 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.
7. 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.
8. Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial.
9. Participant who is an employee or relative of an employee at the research site or Almirall.

Primary outcomes:
measure: Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 110
Secondary outcomes:
measure: Percentage of Participants with Eczema Area and Severity Index (EASI) 50, EASI 75, and EASI 90 (>=50%, >=75%, and >=90%) Reduction in EASI Scores
timeFrame: Baseline up to Week 108
measure: Percentage Change from Baseline of Parent study in EASI Score
timeFrame: Baseline up to Week 108
measure: Percentage of Participants with EASI Score <=7
timeFrame: Baseline up to Week 108
measure: Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1
timeFrame: Baseline up to Week 108
measure: Percentage of Participants Achieving Pruritus Numeric Rating Score (NRS) <= 4
timeFrame: Baseline up to Week 108
measure: Percentage Change From Baseline of Parent Study in Body Surface Area (BSA) Involvement
timeFrame: Baseline to Week 108
measure: Proportion of Participants with Topical Corticosteroids (TCS)-free Days
timeFrame: Baseline up to Week 108
measure: Percentage of Participants with DLQI/CDLQI Score <=5
timeFrame: Baseline up to Week 108
measure: Percentage of Participants Achieving at Least a 4-point Improvement from Baseline of Parent Study Dermatology Quality of Life Index/ Children's Dermatology Quality of Life Index (DLQI/CDLQI)
timeFrame: Baseline to Week 108
Other outcomes:
measure: Number of Participants with TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to Week 110
Locations:
city: Darmstadt
country: Germany
facility: Investigator Site 7
state: Hessen
city: Frankfurt
country: Germany
facility: Investigator Site 8
state: Hessen
city: Osnabrück
country: Germany
facility: Investigator Site 9
state: Lower Saxony
city: Bad Bentheim
country: Germany
facility: Investigator Site 10
state: Niedersachsen
city: Münster
country: Germany
facility: Investigator Site 11
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Investigator Site 12
state: Saxony
city: Augsburg
country: Germany
facility: Investigator Site 1
city: Berlin
country: Germany
facility: Investigator Site 2
city: Berlin
country: Germany
facility: Investigator Site 3
city: Dresden
country: Germany
facility: Investigator Site 4
city: Hamburg
country: Germany
facility: Investigator Site 5
city: Hamburg
country: Germany
facility: Investigator Site 6
city: Wrocław
country: Poland
facility: Investigator Site 23
state: Dolnośląskie
city: Łódź
country: Poland
facility: Investigator Site 24
state: Lodzkie
city: Krakow
country: Poland
facility: Investigator Site 25
state: Malopolskie
city: Kraków
country: Poland
facility: Investigator Site 26
state: Malopolskie
city: Warsaw
country: Poland
facility: Investigator Site 27
state: Mazowieckie
city: Warszawa
country: Poland
facility: Investigator Site 28
state: Mazowieckie
city: Ossy
country: Poland
facility: Investigator Site 29
state: Slaskie
city: Gdańsk
country: Poland
facility: Investigator Site 30
state: Woj. Pomorskie
city: Iwonicz Zdroj
country: Poland
facility: Investigator Site 31
state: Wojewodztwo Podkarpackie
city: Gdansk
country: Poland
facility: Investigator Site 13
city: Katowice
country: Poland
facility: Investigator Site 14
city: Kielce
country: Poland
facility: Investigator Site 15
city: Lublin
country: Poland
facility: Investigator Site 16
city: Poznan
country: Poland
facility: Investigator Site 17
city: Rzeszow
country: Poland
facility: Investigator Site 18
city: Szczecin
country: Poland
facility: Investigator Site 19
city: Tarnow
country: Poland
facility: Investigator Site 20
city: Warszawa
country: Poland
facility: Investigator Site 21
city: Wroclaw
country: Poland
facility: Investigator Site 22
city: Katowice
country: Poland
facility: Investigator Site 32
state: Śląskie
Study officials:
affiliation: Almirall, S.A.
name: Aleksandra Stjepanovic
role: PRINCIPAL_INVESTIGATOR
References: