STARS: Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

• Sponsor: VectivBio AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04627025
• Collaborator: (none)
• Enrollment: 144
• Locations: 77
• Arms: 2
• Anticipated Duration (Months): 33.1
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome	Drug: apraglutide	Phase 3

Detailed Description

This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.

The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)
• Actual Study Start Date: Jan 26, 2021
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apraglutide SC injections, once weekly Peptide analogue of GLP-2	Drug: apraglutide; Apraglutide is a peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.
Placebo Comparator: Placebo Placebo for apraglutide, SC injection once weekly	Drug: apraglutide; Apraglutide is a peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.

Outcome Measures

Primary Outcome Measures

1. Relative change from baseline in actual weekly PS volume. [At week 24 of treatment.]

Secondary Outcome Measures

1. Subjects who achieve a reduction of at least 1 day per week of PS. [Weeks 24 and 48 of treatment]

2. Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48. [Weeks 12 / 24 / 48 of treatment.]

3. SBS-IF patients reaching enteral autonomy at Weeks 24 / 48. [Weeks 24 / 48 of treatment.]

4. At least 20% reduction of PS volume from baseline at Weeks 20 / 24. [Weeks 20 / 24 of treatment.]

5. Calorie reduction in the PN at Weeks 24. [Weeks 24 of treatment.]

6. Change from baseline on the Patient Global Impression of Severity (PGIS) [Weeks 24 / 48 of treatment.]

7. Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) [Weeks 24 / 48 of treatment.]

8. Change from baseline on the Patient Global Impression of Change (PGIC) [Weeks 24 / 48 of treatment.]

9. Absorption rate constant (ka) of apraglutide through population PK data analysis [Weeks 24 / 48 of treatment]

10. Apparent clearance (CL/F) of apraglutide through population PK data analysis [Weeks 24 / 48 of treatment]

11. Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis [Weeks 24 / 48 of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Signed informed consent for this trial prior to any trial specific assessment.

2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).

3. Subject must require PS at least 3 days per work and be considered stable.

4. No restorative surgery intended to change PS requirements in the trial period.

5. Age ≥18 years at screening.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Major abdominal surgery in the last 6 months prior to screening.

3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.

4. Evidence of active inflammatory GI conditions in the previous 6 months.

5. Evidence of decompensated heart failure.

6. Evidence of severe renal or hepatic impairment.

7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
2	Georgetown University Hospital	Washington	District of Columbia	United States	20007
3	Gastroenterology Group of Naples	Naples	Florida	United States	34102
4	University of Illinois, Outpatient Care Center	Chicago	Illinois	United States	60612
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	Boston Children's Hospital	Boston	Massachusetts	United States	02115
7	Henry Ford Medical Center - Columbus	Novi	Michigan	United States	48377
8	Mayo Clinic	Rochester	Minnesota	United States	55905
9	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
10	Mount Sinai Medical Center	New York	New York	United States	10029
11	Duke University Hospital	Durham	North Carolina	United States	27705
12	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
13	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
14	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
15	Vanderbilt University Medical Center, Center for Human Nutrition	Nashville	Tennessee	United States	37212
16	University of Washington Medical Center	Seattle	Washington	United States	98195
17	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
18	University Hospital Foundation Favaloro	Buenos Aires		Argentina
19	Universitair Ziekenhuis Leuven - Gasthuisberg	Leuven	Vlaams Brabant	Belgium	3000
20	University Hospital Brussels	Brussels		Belgium	1090
21	University Hospital Antwerp	Edegem		Belgium	2650
22	University Hospital Brno	Brno		Czechia	62500
23	University Hospital Hradec Kralove	Hradec Králové		Czechia	50005
24	Hospital Novy Jicin	Nový Jičín		Czechia	741 01
25	University Hospital Plzen	Pilsen		Czechia	30460
26	Fakultní nemocnice Královské Vinohrady, II. Interní klinika	Prague		Czechia	10034
27	General University Hospital in Prague	Prague		Czechia	12800
28	Thomayer University Hospital	Prague		Czechia	14059
29	CHU de Caen Normandie	Caen		France	14033
30	Hôpital Beaujon	Clichy		France	92110
31	CHU Hôtel Dieu	Nantes		France	44093
32	Hôpital ARCHET II	Nice		France	6202
33	Hôpital Haut-Lévèque	Pessac		France	33604
34	Hospices Civils de Lyon	Pierre Benite		France	69495
35	Rennes University Hospital Center - Hospital Pontchaillou	Rennes		France	35033
36	Brabois Adults Hospital	Vandœuvre-lès-Nancy		France	54500
37	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117
38	University Hospital Bonn	Bonn		Germany	53127
39	Asklepios Klinik St. Georg	Hamburg		Germany	20099
40	University Hospital Heidelberg	Heidelberg		Germany	69120
41	University Hospital Muenster	Münster		Germany	48149
42	Soroka University Medical Center	Be'er Sheva		Israel	8410101
43	Rambam Health Care Campus	Haifa		Israel	31096
44	Rabin Medical Center	Petah-Tikva		Israel	49100
45	The Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	6423906
46	Sheba Medical Center	Tel HaShomer		Israel	5262000
47	Polyclinic S. Orsola-Malpighi	Bologna		Italy	40138
48	University Polyclinic Foundation "Agostino Gemelli" - IRCCS	Rome		Italy	00168
49	Citta della salute e della Scienza di Torino Hospital	Torino		Italy	10126
50	Toho University Sakura Medical Center	Chiba		Japan	285-8741
51	Fukuoka University Chikushi Hospital	Fukuoka		Japan	818-8502
52	Yokohama Municipal Citizen's Hospital	Kanagawa		Japan	05505
53	Yokohama City University Medical Center	Kanagawa		Japan	232-0024
54	National University Corportation Tohoku University Tohoku University Hospital	Miyagi		Japan	980-8574
55	Osaka University Hospital	Osaka		Japan	565-0871
56	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of	41944
57	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
58	Asan Medical Center	Soeul		Korea, Republic of	05505
59	Samsung Medical Center	Soeul		Korea, Republic of	06351
60	Gjovik Hospital	Gjøvik		Norway	2819
61	Akershus University Hospital	Lørenskog		Norway	1478
62	Alesund Hospital	Ålesund		Norway	6017
63	Stadmedica, Non-Public Healthcare Facility	Bydgoszcz		Poland	85-391
64	COPERNICUS Limited Liability Company	Gdansk		Poland	80-152
65	Gastromed Poland Sp. z o.o.	Lublin		Poland	20-582
66	SOLUMED Medical Center	Poznań		Poland	60-529
67	Stanley Dudrick Multispecialty Hospital	Skawina		Poland	32-050
68	M. Pirogow Provincial Specialized Hospital	Łódź		Poland	90-531
69	University General Hospital Gregorio Maranon	Madrid		Spain	28007
70	University Hospital 12 de Octubre	Madrid		Spain	28041
71	University Hospital Virgen del Rocio	Sevilla		Spain	41013
72	Sahlgrenska University Hospital	Göteborg		Sweden	41345
73	Far Eastern Memorial Hospital	New Taipei City		Taiwan	220
74	China Medical University Hospital (CMUH)	Taichung		Taiwan	40447
75	Taichung Veterans General Hospital	Taichung		Taiwan	40705
76	University College Hospital	London		United Kingdom
77	Salford Royal Hospital	Salford		United Kingdom

Sponsors and Collaborators

• VectivBio AG

Investigators

• Study Director: Seabrook, VectivBio AG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VectivBio AG
• ClinicalTrials.gov Identifier: NCT04627025
• Other Study ID Numbers: TA799-007; 2020-001202-32
• First Posted: Nov 13, 2020
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by VectivBio AG: Short Bowel Syndrome; Intestinal Failure; SBS; SBS-IF; GLP-2; Short Bowel Syndrome Intestinal Failure
• Additional relevant MeSH terms: Short Bowel Syndrome; Syndrome

Study Results

No Results Posted as of Jun 2, 2022