A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants with Severe Alopecia Areata

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

17 Jun 2024 → ongoing

Decision date (initial)

2024-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-505061-82-01

ClinicalTrials.gov

NCT06012240

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Objective:
Study 1 and Study 2:
Double-blind Period, Baseline to Week 24 (Period A):
·To assess the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD compared with placebo for the treatment of signs and symptoms of severe AA in adult subjects and adolescent subjects
Blinded Extension Period, Week 24 to Week 52 (Period B):
·To evaluate the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD in extended treatment in adult and adolescent subjects with severe AA

Study 3
Randomized Blinded Extension Period, Week 52 to Week 160:
·To assess the long-term safety and efficacy of the following treatments in adult and adolescent subjects with severe AA:
·Continuous upadacitinib 30 mg QD treatment
·Dose reduction to 15 mg QD in subjects who achieve sustained response in Study 1, Study 2 or study 4 defined as a Severity of Alopecia Tool (SALT) score ≤ 20 at Week 40 and Week 52
·Continuous upadacitinib 15 mg QD treatment
·Dose escalation to 30 mg QD in subjects who have not achieved a SALT score ≤ 20 at Week 52 in Study 1, Study 2 or study 4 or who lose response during Study 3

Study 4 (US only):
Double-blind Period, Baseline to Week 24 (Period A):
• To assess the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD and placebo for the treatment of signs and symptoms of severe AA in adolescent subjects in the US
Blinded Extension Period, Week 24 to Week 52 (Period B):
• To evaluate the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD in extended treatment in adolescent subjects with severe AA in the US

Conditions and MedDRA coding

Alopecia Areata

Study design 1 period

Regulatory references

Scientific advice from competent authorities

AbbVie AB

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Eligible subjects will be adults < 64 years old at Baseline and, where permitted outside US/EU adolescents at least 12 years old at Screening with a diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline and no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months
2. Must have current episode of AA of less than 8 years.

Exclusion criteria 3

1. Subject has a diagnosis of primarily diffuse type of AA
2. Subject has a diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium.
3. Subject has a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Study 1 and Study 2 The primary endpoint is the achievement of SALT score ≤ 20 at Week 24, defined as less than or equal to 20% scalp hair loss.

Secondary endpoints 19

1. Achievement of SALT score <= 10 at Week 24
2. Achievement of SALT score <= 20 at Week 12
3. Achievement of ClinRO measure for Eyebrow Hair Loss of 0 or 1 at Week 24 with a ≥ 2-point improvement (reduction) from Baseline among subjects with Baseline score ≥ 2
4. Achievement of ClinRO measure for Eyelash Hair Loss of 0 or 1 at Week 24 with a ≥ 2-point improvement (reduction) from Baseline among subjects with Baseline score ≥ 2
5. Achievement of SALT 75 at Week 24
6. Achievement of SALT 90 (at least a 90% improvement [decrease] from Baseline in SALT score) at Week 24
7. Percent change from Baseline in SALT score at Week 24
8. Achievement of PaGIC-AA score of 1 "much better" or 2 "moderately better" at Week 24
9. Achievement of PRO for Scalp Hair Assessment 0/1 with ≥ 2-point improvement (reduction) from Baseline at Week 24 among subjects with Baseline score ≥ 3
10. Change from Baseline in Skindex-16 AA Emotions Domain scores at Week 24
11. Change from Baseline in Skindex-16 AA Functioning Domain scores at Week 24
12. Change from Baseline in AASIS Interference Subscale score at Week 24
13. Change from Baseline in AASIS Symptoms Subscale score at Week 24
14. ·Achievement of HADS-A < 8 and HADS-D < 8 at Week 24 among subjects with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline
15. Achievement of SALT score 0 at Week 24
16. Achievement of SALT score ≤ 20 at Week 8
17. Achievement of PaGIC-AA score of 1 "much better" or 2 "moderately better" at Week 4
18. Achievement of SALT score ≤ 20 at Week 4
19. Achievement of SALT score <= 20 at Week 24, for the comparison of upadacitinb 15 mg QD versus placebo

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 9

Locations

13 EU/EEA countries · 79 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 206 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