Debio 4126 for Acromegaly
(OXTEND™-03 Trial)
Recruiting at 1 trial location
DI
Overseen ByDebiopharm International S.A
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Debiopharm International SA
Must be taking: Octreotide, Lanreotide
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
Eligibility Criteria
This trial is for adults over 18 with acromegaly, who have been treated with somatostatin analogs like octreotide or lanreotide for at least 6 months. Their IGF-1 levels must be within the normal range and they should have good bone marrow, liver, and kidney function. Participants need to maintain their IGF-1 levels to move into the second phase of the study.Inclusion Criteria
I meet other specific requirements for the study.
My IGF-1 levels are normal or below.
My IGF-1 levels are normal or below without needing extra medication until Week 34-48.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Double-blind Treatment
Participants receive an IM injection of Debio 4126 or placebo once every 12 weeks over a total of 36 weeks
36 weeks
3 visits (in-person)
Open-label Treatment
Eligible participants receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks
24-60 weeks
2-5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Debio 4126
Trial Overview The study tests Debio 4126's ability to keep insulin-like growth factor 1 (IGF-1) levels normal in people with acromegaly compared to a placebo. It's a blind test where neither doctors nor patients know who gets the real drug or placebo until after week 36.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm C: Debio 4126 (Open-Label Treatment Period)Experimental Treatment1 Intervention
During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).
Group II: Arm A: Debio 4126Experimental Treatment1 Intervention
During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Group III: Arm B: Placebo + Debio 4126Placebo Group2 Interventions
During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication.
Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
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Who Is Running the Clinical Trial?
Debiopharm International SA
Lead Sponsor
Trials
53
Recruited
7,300+
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