A Phase 3 randomized 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126), to assess the efficacy and safety of Debio 4126, a 12-week octreotide formulation, in patients with acromegaly previously treated with somatostatin analogs.

Conditions

Acromegaly

Brief summary

Percentage of participants with IGF-1 ≤1x ULN at W36, where IGF-1 will be based on the average of 2 samples acquired at W34 and W36. If this average IGF-1 is ≤1x ULN, a participant is classified as a responder

Detailed description

Percentage of Participants With IGF-1 ≤1x ULN at W36, in Arm C, Change From Baseline in IGF-1 Values, Percent Change From Baseline in IGF-1 Values, Percentage of Participants With IGF-1 ≤1x ULN, Percentage of Participants With GH Level <1 ng/mL, Change From Baseline in GH Values, Mean Logarithm With Base 10 (Log10) Change From Baseline in GH Values, Percentage of Participants With GH Value per Category (<1; ≥1 and <2.5; ≥2.5 (ng/mL), Number of Participants With at Least one Treatment-Emergent Adverse Event (TEAE), in Arms A and B, up to W36, Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, Electrocardiogram (ECG), and Pituitary Tumor Size, in Arms A and B, up to W36, Number of Participants With at Least one TEAE in Arms A, B and C, Time-at-Risk Exposure-Adjusted Incidence Rate for TEAEs, Total Participant-Years at-Risk for TEAEs, Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, ECG, and Pituitary Tumor Size in Arms A, B and C, Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment, Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score, Percentage of Participants Taking Rescue Medication, PK parameters of Debio 4126, including but not limited to octreotide concentration at the end of the 12-week Treatment Interval (Ctrough)

Related papers

No related papers found yet.

Interventions

DRUGLANREOTIDE

DRUGDebio 4126

DRUGReady-to-use suspension resembling 30

DRUG60

DRUGor 90 mg Debio 4126 doses

DRUGOCTREOTIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants with IGF-1 ≤1x ULN at W36, where IGF-1 will be based on the average of 2 samples acquired at W34 and W36. If this average IGF-1 is ≤1x ULN, a participant is classified as a responder	—

Secondary

Measure	Time frame
Percentage of Participants With IGF-1 ≤1x ULN at W36, in Arm C, Change From Baseline in IGF-1 Values, Percent Change From Baseline in IGF-1 Values, Percentage of Participants With IGF-1 ≤1x ULN, Percentage of Participants With GH Level <1 ng/mL, Change From Baseline in GH Values, Mean Logarithm With Base 10 (Log10) Change From Baseline in GH Values, Percentage of Participants With GH Value per Category (<1; ≥1 and <2.5; ≥2.5 (ng/mL), Number of Participants With at Least one Treatment-Emergent Adverse Event (TEAE), in Arms A and B, up to W36, Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, Electrocardiogram (ECG), and Pituitary Tumor Size, in Arms A and B, up to W36, Number of Participants With at Least one TEAE in Arms A, B and C, Time-at-Risk Exposure-Adjusted Incidence Rate for TEAEs, Total Participant-Years at-Risk for TEAEs, Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs,	—

Measure

Time frame

Percentage of Participants With IGF-1 ≤1x ULN at W36, in Arm C, Change From Baseline in IGF-1 Values, Percent Change From Baseline in IGF-1 Values, Percentage of Participants With IGF-1 ≤1x ULN, Percentage of Participants With GH Level <1 ng/mL, Change From Baseline in GH Values, Mean Logarithm With Base 10 (Log10) Change From Baseline in GH Values, Percentage of Participants With GH Value per Category (<1; ≥1 and <2.5; ≥2.5 (ng/mL), Number of Participants With at Least one Treatment-Emergent Adverse Event (TEAE), in Arms A and B, up to W36, Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs, Electrocardiogram (ECG), and Pituitary Tumor Size, in Arms A and B, up to W36, Number of Participants With at Least one TEAE in Arms A, B and C, Time-at-Risk Exposure-Adjusted Incidence Rate for TEAEs, Total Participant-Years at-Risk for TEAEs, Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Vital Signs,

—

Countries

Austria, Belgium, Bulgaria, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed