Diagnosed With Acromegaly, Currently in the Active Stage of the Disease
Conditions
Brief summary
he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.
Detailed description
This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study evaluating the efficacy and safety of octreotide long-acting injection in patients with acromegaly. The purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in treating acromegaly. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres(Sandostatin LAR®) cohort. A total of 154 participants are expected to be enrolled. The study will consist of a maximum 4-week screening/Baseline period, followed by 28-week treatment period.
Interventions
DRUGSYHX2008
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
DRUGSandostatin LAR®
The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study .
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants aged 18 to 80 years (including boundary values) * Diagnosed with acromegaly, currently in the active stage of the disease (for patients who have not undergone pituitary tumor surgery before, MRI shows a pituitary mass, fasting GH ≥ 2.5 ng/mL and IGF-1 index ≥ 1.3; for patients who have undergone pituitary tumor surgery, fasting GH ≥ 2.5 ng/mL and IGF-1 index ≥ 1.3)；
Exclusion criteria
* Have received pituitary radiotherapy within the 5 years prior to screening * Have undergone major surgery (including pituitary surgery) within 6 months prior to screening or are expected to require surgery (including pituitary surgery) or radiotherapy during the study period * Within three months before the screening, participants received drugs such as long-acting lanretide, long-acting octreotide, pervesomone, and cabergoline, or traditional Chinese medicines for treating acromegaly. Receive bromocriptine within one month before screening; Received short-acting octreotide or lanretide short-acting preparations for treatment within 7 days before screening; Or have received any other investigational drug within 30 days before screening or within 5 half-lives (whichever is longer) * Previous failure to respond to octreotide or lantreotide monotherapy (defined as: after at least 3 months of treatment with octreotide microspheres ≥30 mg or lantreotide ≥120 mg, or after at least 3 months of treatment with parietide microspheres ≥40 mg, random GH ≥2.5 ng/mL and/or IGF-1 index ≥1.3) or history of intolerance. * Participants with obvious visual field defects caused by optic chiasm compression and requiring surgical intervention * HbA1c\>8.5%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with an IGF-1 index ≤ 1.0 | Week 28 | insulin-like growth factor-1 within the normal range after adjustment for age and gender, where IGF-1 index = IGF-1 value/ULN, and ULN is the upper limit of the normal reference range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with fasting GH less than 2.5 ng/mL and IGF-1 index less than or equal to 1.0 | weeks 4、8、12、16、20、24、28 | — |
| The proportion of patients with GH less than 1.0 ng/mL and IGF-1 index less than or equal to 1.0 | weeks 4、8、12、16、20、24、28 | — |
| The proportion of patients with fasting GH < 1.0 ng/mL | Weeks 4、8、12、16、20、24、28 | — |
| The proportion of patients with fasting GH<2.5 ng/mL | Weeks 4、8、12、16、20、24、28 | — |
| The proportion of patients with an IGF-1 index ≤ 1.0 | Weeks 4、8、12、16、20、24 | insulin-like growth factor-1 within the normal range after adjustment for age and gender, where IGF-1 index = IGF-1 value/ULN, and ULN is the upper limit of the normal reference range |
| The rate of change in the volume of the pituitary tumor from the baseline | Weeks 28 | — |
| The change in the total PASQ score from the baseline | Weeks 12、28 | Evaluation of effect on was assessed using Patient Assessed Acromegaly Symptom Question ( PASQ ), an acromegaly-specific quality of life instrument. |
| The change in the total AcroQoL score from the baseline | Weeks 12、28 | Evaluation of effect was assessed using Acromegaly Quality of Life Questionnaire（AcroQoL）, an acromegaly-specific quality of life instrument. |
| The proportion of patients with fasting GH decreased by ≥50% compared to the baseline | Weeks 4、8、12、16、20、24、28 | — |
| The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline | Weeks 4、8、12、16、20、24、28 | — |
| Percentage changes in fasting GH from baseline | Weeks 4、8、12、16、20、24、28 | — |
| Percentage changes in IGF-1 from baseline | Weeks 4、8、12、16、20、24、28 | — |
| Incidence of adverse events (AE) | From the signing of informed consent up to 28 Weeks after the first dose | Proportion of subjects with adverse events (AEs) within Weeks 28 |
| The concentration of octreotide | From the signing of informed consent up to 28 Weeks afterthe first dose | The concentration of octreotide in the plasma of patients with acromegaly after administration of SYHX2008 injection and Sandostatin LAR® |
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed