A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Camurus AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

3 Jun 2021 → 25 Apr 2025

Decision date (initial)

2024-04-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

CAMURUS AB

External identifiers

EU CT number

2024-510667-33-00

EudraCT number

2019-002190-66

ClinicalTrials.gov

NCT04125836

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Therapy, Efficacy, Safety

Main part of the trail: To assess the overall safety and tolerability of CAM2029
Extension part of the trial: To assess the overall safety and tolerability of CAM2029

Secondary objectives 10

1. Main part of the trail: To assess efficacy of CAM2029 based on biochemical characteristics
2. Main part of the trail: To assess self-and partner administration
3. Main part of the trail: To assess plasma concentration of octreotide after administration of CAM2029
4. Main part of the trail: To measure patients' satisfaction with CAM2029
5. Main part of the trail: To measure the effects of CAM2029 on quality of life (QoL)
6. Extension part of the trial: To assess efficacy of CAM2029 based on biochemical characteristics
7. Extension part of the trial: To evaluate patients' satisfaction with CAM2029
8. Extension part of the trial: To evaluate the effects of CAM2029 on QoL
9. Extension part of the trial: To evaluate the effects of CAM2029 on health economic outcomes
10. Extension part of the trial: To evaluate solicited safety assessments after treatment with CAM2029

Conditions and MedDRA coding

Acromegaly

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Main part of the trail: Male or female patients > =18 years at screening
2. Main part of the trail: Able to provide written informed consent to participate in the trial
3. Main part of the trail: Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly
4. Main part of the trail: Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
5. Main part of the trail: IGF-1 levels >1xULN and ≤2.0xULN at screening (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1) or IGF-1 levels <=1xULN at screening (adjusted for age and sex; value of the first measurement at screening and the second measurement at 2 weeks before Day 1) either without prior pituitary radiotherapy or with prior pituitary radiotherapy
6. Main part of the trail: Adequate liver, pancreatic, renal and bone marrow functions
7. Main part of the trail: Normal ECG
8. Extension part of the trial: Continuation Criteria for Patients who Continue Directly to the Extension Part of the Trial: Patients who continue directly from the main part of the trial must complete treatment with CAM2029 in the main part of the trial, attend the Week 52 visit, and provide written informed consent to continue treatment in the extension part of the trial before treatment can be continued.
9. Extension part of the trial: Main Inclusion Criteria for Re-invited Patients: Completed treatment with CAM2029 in the main part of the trial and attended the Week 52 visit. Adequate liver, pancreatic and renal functions. Normal ECG.

Exclusion criteria 10

1. Main part of the trail: For roll-over patients from trial HS-18-633: Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
2. Main part of the trail: For roll-over patients from trial HS-18-633: Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
3. Main part of the trail: For new patients: Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer])
4. Main part of the trail: For new patients: Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
5. Main part of the trail: For new patients: Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
6. Main part of the trail: For new patients: Patients who have undergone major surgery/surgical therapy for any cause within 1 month prior to screening
7. Main part of the trail: For new patients: Patients who have undergone pituitary surgery within 6 months prior to screening
8. Main part of the trail: For new patients: Patients who have received prior pituitary irradiation within 3 years prior to screening
9. Main part of the trail: For new patients: Patients with poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] >8.0%)
10. Main Exclusion Criteria for Re-invited Patients -Extension Part of the Trial: Receiving treatments (other than treatments for acromegaly) known to affect GH or IGF-1 concentration. Patients who have undergone major surgery/surgical therapy (including pituitary surgery) for any cause within 1 month prior to screening. Patients who have received pituitary irradiation since the end of the main part of the trial. Patients with poorly controlled diabetes mellitus (HbA1c >8.0%).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Main part and Extension part of the trial: Characterization of adverse events (AEs)

Secondary endpoints 13

1. Main part of the trail: Proportion of patients with mean IGF-1 levels ≤1 x upper limit of normal (ULN) and <1.3xULN at Week 50 and Week 52 (average of the 2 measurements)
2. Main part of the trail: Proportion of patients with mean GH levels <2.5 μg/L and <5.0 μg/L at Week 52
3. Main part of the trail: Proportion of patients/partners declared competent by healthcare professional to administer CAM2029
4. Main part of the trail: Octreotide plasma concentrations over time
5. Main part of the trail: Treatment Satisfaction Questionnaire for Medication (TSQM) scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction)
6. Main part of the trail: Patient satisfaction scale scores at Week 24 and Week 52
7. Main part of the trail: Change from baseline in Acromegaly Quality of Life Questionnaire (AcroQoL) and EuroQoL 5-dimension 5-level (EQ-5D-5L) scores
8. Extension part of the trial: IGF-1 levels over time
9. Extension part of the trial: GH levels over time
10. Extension part of the trial: TSQM scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and satisfaction)
11. Extension part of the trial: AcroQoL, EQ-5D-5L and Short Form-36 (SF-36) scores over time
12. Extension part of the trial: Work Productivity and Activity Impairment (WPAI) scores over time
13. Extension part of the trial: Laboratory values, vital signs, ECG readings and gallbladder imaging over time

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Camurus AB

Sponsor organisation

Camurus AB

Address

Rydbergs Torg 4

City

Lund

Postcode

224 84

Country

Sweden

Scientific contact point

Organisation

Camurus AB

Contact name

VP Clinical Development

Public contact point

Organisation

Camurus AB

Contact name

VP Clinical Development

Third parties 9

Locations

5 EU/EEA countries · 19 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 41 files

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

Application history

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