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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Almirall S.A.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

23 May 2023 → 23 Apr 2026

Decision date (initial)

2023-05-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Almirall, S.A.

External identifiers

EU CT number

2022-502575-30-00

WHO UTN

U1111-1286-6648

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To examine the long-term tolerability of lebrikizumab 250 mg Q4W in adults and adolescents with moderate-to-severe Atopic Dermatitis, in consideration of treatment discontinuations due to Adverse Events over 2 years

Secondary objectives 2

1. To evaluate the effectiveness of lebrikizumab 250 mg Q4W administered up to 2 years in controlling disease signs and symptoms in adults and adolescents with moderate-to- severe Atopic Dermatitis.
2. To evaluate the impact lebrikizumab 250 mg Q4W administered up to 2 years on patient-reported quality of life in adults and adolescents with moderate-to-severe Atopic Dermatitis.

Conditions and MedDRA coding

Atopic Dermatitis

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients who completed treatment with lebrikizumab in ADjoin and their last patient 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 patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation 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 Section 14.2 of the Protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria 9

1. Patients 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. Patients 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 patient.
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 patient from the study (eg, 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 (see Section 9.9.2) 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 patient’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 patient’s participation unreliable, or may interfere with study assessments.
8. Any other conditions that, in the Investigator’s opinion, might indicate the patient to be unsuitable for the trial.
9. Patient who is an employee or relative of an employee at the research site or Almirall.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients discontinued from study treatment due to treatment-emergent AEs through the last study visit.

Secondary endpoints 13

1. Percentage of patients with EASI 50, EASI 75, and EASI 90 (≥50%, ≥75%, and ≥90% reduction in EASI scores from baseline of parent study, respectively) by visit.
2. Percentage change from baseline of parent study in EASI score by visit.
3. Percentage of patients with EASI score ≤7 by visit.
4. Percentage of patients achieving IGA 0/1 by visit.
5. Percentage of patients achieving Pruritus NRS score of 0/1 by visit.
6. Percentage of patients achieving Pruritus NRS score ≤4 by visit.
7. Percentage change from baseline of parent study* in POEM by visit.
8. Percentage change from baseline of parent study* in BSA involvement by visit.
9. Proportion of TCS-free days from baseline by visit.
10. Percentage of patients with DLQI ≥4 at baseline achieving ≥ 4-point improvement from baseline of parent study in DLQI score by visit
11. Percentage of patients with CDLQI ≥6 at baseline achieving ≥6-point improvement from baseline of parent study* in CDLQI score by visit.
12. Percentage of participants achieving DLQI ≤5 by visit
13. Percentage of participants achieving CDLQI ≤6 by visit.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Almirall S.A.

Sponsor organisation

Almirall S.A.

Address

Ronda General Mitre 151

City

Barcelona

Postcode

08022

Country

Spain

Scientific contact point

Organisation

Almirall S.A.

Contact name

Yanislav Mihaylov

Public contact point

Organisation

Almirall S.A.

Contact name

Estrella Garcia

Third parties 3

Locations

2 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications