Osteogenesis Imperfecta Trial of AGA2115 for ADUlts with COL1A1 and/or COL1A2 GeNetic Variations (IDUN)

2025-522951-24-00 Protocol ACT24-001 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 2 EU/EEA countries · 5 sites · Protocol ACT24-001

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 98
Countries 2
Sites 5

Osteogenesis Imperfecta

To determine the effect of AGA2115 on BMD at the lumbar spine at Month 12

Key facts

Sponsor
Angitia Inc. Ltd.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Decision date (initial)
2026-06-22
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
No
Funding sources
Angitia Incorporated Limited

External identifiers

EU CT number
2025-522951-24-00
ClinicalTrials.gov
NCT07062588

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others, Pharmacokinetic

To determine the effect of AGA2115 on BMD at the lumbar spine at Month 12

Conditions and MedDRA coding

Osteogenesis Imperfecta

VersionLevelCodeTermSystem organ class
20.0 PT 10031243 Osteogenesis imperfecta 100000004850

Regulatory references

Scientific advice from competent authorities
Food And Drug Administration, European Medicines Agency
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes
  2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
  3. BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck

Exclusion criteria 12

  1. Vitamin D deficiency
  2. Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders
  3. Current hyper- or hypocalcemia
  4. History of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
  5. Treatment with bisphosphonates within the past 6 months
  6. Treatment with teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months
  7. Treatment with denosumab (or denosumab biosimilars) within the past 2 years
  8. Treatment with anti-sclerostin antibody medications (romosozumab, setrusumab, blosozumab) at any time
  9. History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant) within the past 12 months
  10. Malignancy within the last 5 years
  11. Pregnant or breastfeeding women, or women planning to become pregnant during the study
  12. Participation in any clinical study within the past 12 months during which the participant was administered any IP (participant must also agree not to enroll in any other clinical study concurrently in which IP is administered)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percent change from Baseline at Month 12 in lumbar spine BMD

Investigational products

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

Test 1

AGA2115

PRD12774295 · Product

Active substance
Humanised IGG4 Bispecific Monoclonal Antibody Against Sclerostin and Dickkopf-Related Protein 1
Substance synonyms
AGA2115
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
2000 mg milligram(s)
Max total dose
48000 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Not Authorised
MA holder
ANGITIA INC. LTD.
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/25/3069

Placebo 1

Placebo to match AGA2115

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Angitia Inc. Ltd.

2 Total trials 1 Recruiting
Commercial
Sponsor organisation
Angitia Inc. Ltd.
Address
3027 Townsgate Road Ste 220
City
Westlake Village
Postcode
91361-5864
Country
United States

Scientific contact point

Organisation
Angitia Inc. Ltd.
Contact name
Ricardo Dent, MD

Public contact point

Organisation
Angitia Inc. Ltd.
Contact name
Deborah Lium

Third parties 13

OrganisationCity, countryDuties
Centre hospitalier universitaire de Liege
ORG-100011851
 Liege, Belgium Other, Laboratory analysis
Innovative Trials Limited
ORG-100044081
 Letchworth Garden City, United Kingdom Other
Worldwide Clinical Trials d.o.o.
ORG-100030991
 Zagreb, Croatia On site monitoring, Code 10, Code 11, Code 12, Other, Code 2, Code 5, Data management, Code 9
Merative US LP
ORG-100046293
 Ann Arbor, United States Other
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Code 8
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Image Analysis Limited
ORG-100049566
 London, United Kingdom Other
Suvoda LLC
ORG-100043523
 Conshohocken, United States Interactive response technologies (IRT)
Catalent Germany Schorndorf GmbH
ORG-100011845
 Schorndorf, Germany Code 14
Biologics Development Services LLC
ORG-100044619
 Tampa, United States Other, Laboratory analysis
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Triumph Research Intelligence Limited
ORG-100050298
 Cambridge, United Kingdom Other
Icon Laboratory Services Inc.
ORG-100037135
 Farmingdale, United States Other, Laboratory analysis

Locations

2 EU/EEA countries · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruitment pending 15 2
Netherlands Authorised, recruitment pending 15 3
Rest of world
United Kingdom, Argentina, United States, Canada, Australia
 — 68 —

Investigational sites

Denmark

2 sites · Authorised, recruitment pending
Odense University Hospital
Endokrinologisk afdeling M, Kloevervaenget 47, 5000, Odense C
Region Midtjylland
Medicinsk Endokrinologisk Afdeling (MEA), Palle Juul-Jensens Boulevard 175, 8200, Aarhus N

Netherlands

3 sites · Authorised, recruitment pending
Isala Klinieken Stichting
Internal Medicine, Dokter Van Heesweg 2, 8025 AB, Zwolle
Leids Universitair Medisch Centrum (LUMC)
Center for Bone Quality, P. O. Box 9600, 2300 RC, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Results and documents

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

Documents 22 files

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

TypeTitleVersion
Protocol (for publication) D1_ACT24-001_Protocol_redacted Amd 1
Protocol (for publication) D4_ACT24-001_Survey_Placeholder_Public N/A
Recruitment arrangements (for publication) K1_ACT24-001_DNK_Recruitment arrangements_Public 1.2
Recruitment arrangements (for publication) K1_ACT24-001_NLD_Recruitment Arrangements_public 1.2
Recruitment arrangements (for publication) K2_ACT24-001_DNK_Patient Handout_da_Redacted 2.0
Recruitment arrangements (for publication) K2_ACT24-001_DNK_Study Flyer_da_Redacted 2.0
Recruitment arrangements (for publication) K2_ACT24-001_NLD_Patient Handout_nl_redacted 2.0
Recruitment arrangements (for publication) K2_ACT24-001_NLD_Study Flyer_nl_redacted 2.0
Recruitment arrangements (for publication) K2_Clinician Recruitment Letter_Redacted 1.0
Subject information and informed consent form (for publication) L1_ACT24-001_DNK_Main-ICF_Addendum_da_Public 1.1
Subject information and informed consent form (for publication) L1_ACT24-001_DNK_Main-ICF_da_Redacted 1.2
Subject information and informed consent form (for publication) L1_ACT24-001_DNK_Optional-ICF_da_Redacted 1.2
Subject information and informed consent form (for publication) L1_ACT24-001_DNK_Prescreening-ICF_da_Redacted 1.2
Subject information and informed consent form (for publication) L1_ACT24-001_NLD_Main-ICF_nl_redacted 1.3
Subject information and informed consent form (for publication) L1_ACT24-001_NLD_Optional-ICF_nl_redacted 1.3
Subject information and informed consent form (for publication) L1_ACT24-001_NLD_Pre-screening-ICF_nl_redacted 1.2
Subject information and informed consent form (for publication) L1_ACT24-001_NLD_Pregnancy-ICF_nl_redacted 1.3
Subject information and informed consent form (for publication) L2_Subjects Rights Information N/A
Synopsis of the protocol (for publication) D1_ACT24-001_DNK_Protocol Lay Summary_en_redacted 1.0
Synopsis of the protocol (for publication) D1_ACT24-001_FRA_Protocol Lay Summary_fr_redacted 1.1
Synopsis of the protocol (for publication) D1_ACT24-001_NLD_Protocol Lay Summary_nl_redacted 1.0
Synopsis of the protocol (for publication) D1_ACT24-001_Protocol Synopsis_redacted Amd 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-02-27 Denmark Acceptable with conditions
2026-06-22
 2026-06-22

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