Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
60
Countries
3
Sites
12
Ulcerative Colitis
To characterize the safety and efficacy of ABBV-668 as treatment in adult subjects with moderately to severely active UC.
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 10 Aug 2023 → 23 Dec 2024
- Decision date (initial)
- 2023-07-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-501263-41-00
- ClinicalTrials.gov
- NCT05570006
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To characterize the safety and efficacy of ABBV-668 as treatment in adult subjects with moderately to severely active UC.
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 2a, multicenter, open label proof of concept study to investigate the efficacy and safety The study contains a 30-day screening period, 16-week treatment period, and a 30-day follow up period from the last dose of study drug.
|
2 | None | Single arm: Single arm |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult male or female, at least 18 years old at time of the Baseline visit.
- Diagnosis of UC for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
- Subject meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or biologics or targeted immunomodulators.
Exclusion criteria 1
- Anything other than a positive response to the questions in section 5.1 Eligibility Criteria of the Protocol will result in exclusion from study participation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the achievement of endoscopic improvement (Mayo ESS of 0 or 1) at Week 8.
Secondary endpoints 5
- The estimands corresponding to the secondary efficacy objectives are: For each binary secondary endpoint specified in Section 3.3: The difference in the proportion of subjects achieving a response in ABBV-668 treatment group in the ITT Population versus in historical placebo group, where subjects will be counted as non-responders after the start of rescue medication (initiation or dose escalation of UC-related corticosteroids).
- Achievement of clinical remission per Adapted Mayo score at Week 8.
- Achievement of clinical response per Adapted Mayo score at Week 8.
- Achievement of clinical response per Partial Adapted Mayo score at Week 8.
- Achievement of endoscopic remission at Week 8.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10000611 · Product
- Active substance
- ABBV-668
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE, INC.
- Paediatric formulation
- No
- Orphan designation
- No
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 Clinial Trial Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 8 | 4 |
| France | Ended | 8 | 4 |
| Poland | Ended | 20 | 4 |
| Rest of world
United States
|
— | 24 | — |
Investigational sites
Universitair Ziekenhuis Gent
Gastro-enterologie, Corneel Heymanslaan 10, 9000, Gent
CHC
Gastro enterologie, Rue De Hesbaye 75, 4000, Liege
UZ Leuven
Gastro-enterologie, Herestraat 49, 3000, Leuven
Verenigde Ziekenhuizen van Waas en Durme
Gastro-enterologie, Moerlandstraat 1, 9100, Sint-Niklaas
Centre Hospitalier Universitaire De Saint Etienne
Service Hepato-Gastroenterologie et Oncologie Digestive, Avenue Albert Raimond, 42270, Saint-Priest-En-Jarez
Hopital Saint Eloi
Service Hépato-gastro-entérologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Medico Chirurgical Ambroise Pare Hartmann
Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire Grenoble Alpes
Service Hepato-Gastroenterologie et Oncologie Digestive, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Gastromed Sp. z o.o.
GASTROMED, Ul. Grudziadzka 11/13-14, 87-100, Torun
H-T.Centrum Medyczne Sp. z o.o.
H-T. Centrum Medyczne – Endoterapia, Aleja Bielska 105, 43-100, Tychy
WIP Warsaw IBD Point
WIP Warsaw IBD Point Profesor Kierkus, ul. Bobrowiecka 9B, 00-728, Warszawa
Endoskopia Sp. z o.o.
Endoskopia Sp. z o.o., Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-08-10 | 2024-09-27 | 2024-04-02 | 2024-08-09 | |
| France | 2023-10-25 | 2024-10-15 | 2023-11-08 | 2024-08-09 | |
| Poland | 2023-11-30 | 2024-12-05 | 2024-01-03 | 2024-08-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| CTIS M21-446 Final Results SUM-110041
|
2025-12-08T17:51:35 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| M21-446 Results Lay Summary | 2025-12-08T21:18:13 | Submitted | Laypersons Summary of Results |
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | m21446-results-lay-summary-de-be | 1 |
| Laypersons summary of results (for publication) | m21446-results-lay-summary-en-en | 1 |
| Laypersons summary of results (for publication) | m21446-results-lay-summary-fr-be | 1 |
| Laypersons summary of results (for publication) | m21446-results-lay-summary-fr-fr | 1 |
| Laypersons summary of results (for publication) | m21446-results-lay-summary-nl-be | 1 |
| Laypersons summary of results (for publication) | m21446-results-lay-summary-pl-pl | 1 |
| Protocol (for publication) | m21446-protocol-eu_public_Redacted | V2.1 |
| Recruitment arrangements (for publication) | M21-446 PL - Ad and Recruitment Materials - Brochure_public redacted | 1 |
| Recruitment arrangements (for publication) | M21-446 PL - Ad and Recruitment Materials_Flyer_public redacted | 1 |
| Recruitment arrangements (for publication) | M21-446 PL Recruitment and ICF Procedures_public redacted | 1 |
| Subject information and informed consent form (for publication) | M21-446 PL - ICF Main Country Informed Consent Form_public redacted | 2 |
| Summary of results (for publication) | CTIS M21-446_EU Final Results | 1 |
| Synopsis of the protocol (for publication) | M21-446 BE Protocol Synopsis - Global - Dutch_redacted_public | 2 |
| Synopsis of the protocol (for publication) | M21-446 BE Protocol Synopsis - Global - French_redacted_public | 2 |
| Synopsis of the protocol (for publication) | M21-446 FR Protocol Synopsis - Global - French_redacted_public | 1 |
| Synopsis of the protocol (for publication) | M21-446 PL Protocol Synopsis - Global - Polish - public_Redacted | 2.1 |
| Synopsis of the protocol (for publication) | M21-446-protocol-synopsis-redacted_public | 2 |
| Synopsis of the protocol (for publication) | m21446-protocol-eu-synopsis_public_Redacted | 2.1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M21-446 Lay Version BE Dutch_public | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M21-446 Lay Version BE French_public | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M21-446 Lay Version BE German_public | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis Study M21-446-Lay version - English_public | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-28 | France | Acceptable with conditions 2023-07-17
|
2023-07-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-27 | Acceptable with conditions | 2023-09-04 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-01 | France | Acceptable with conditions | 2023-09-14 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2023-08-14 | Acceptable with conditions 2023-07-17
|
2023-11-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-10 | France | Acceptable with conditions | 2024-06-18 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-06-26 | |||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-01 | 2024-10-01 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-12 | Acceptable 2025-03-03
|
2025-03-09 |