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Alxn1850

Clinical trials are investigating Alxn1850 in people with hypophosphatasia (HPP), a rare bone disease. These studies are looking at whether Alxn1850 is effective and safe in children, teenagers, and adults, including people who have not used asfotase alfa before and those previously treated with it.

Table of Contents

Trial overview

Alxn1850 is being studied in hypophosphatasia, also called HPP, which is the condition named in all of the listed trials.[1][2][3] All three studies are Phase 3 and are interventional trials, meaning researchers are giving a study treatment and measuring what happens.[1][2][3]

The trials are focused on different age groups and treatment histories.[1][2][3] Two studies are for participants who have not previously been treated with asfotase alfa, and one study is for pediatric participants who were previously treated with asfotase alfa.[1][2][3]

Who is being studied

One study includes treatment-naïve pediatric participants, which means children who have not been treated before with asfotase alfa.[1] Another study includes pediatric participants with HPP who were already treated with asfotase alfa.[2]

The third study includes adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.[3] This shows that the research program is looking at Alxn1850 across different ages and different treatment backgrounds.[1][2][3]

What the trials measure

The pediatric study in treatment-naïve participants measures the RGI-C score at the end of the randomized evaluation period on Day 169.[1] This is a radiographic outcome, which means it looks at changes seen on imaging such as X-rays.[1]

The adolescent and adult study measures change from baseline in the 6-minute walk test at Day 169.[3] This test shows how far a person can walk in 6 minutes and is used here as a functional outcome, meaning it helps measure how well the body works in daily life.[3]

The pediatric study in participants previously treated with asfotase alfa focuses on safety and tolerability, using outcomes such as the incidence of TEAEs, TESAEs, AESIs, and adverse events that lead to stopping or pausing study treatment.[2] These terms describe different kinds of unwanted medical events during the study, from general side effects to serious events and events of special interest.[2]

What the studies compare

Two trials compare Alxn1850 with placebo, which is an inactive product used to make the comparison fair.[1][3] This helps researchers see whether changes are due to Alxn1850 rather than to chance or to the trial setting.[1][3]

The pediatric safety study compares Alxn1850 with asfotase alfa, which is listed in the trial record as Strensiq.[2] This comparison is used to assess safety and tolerability in children who have already received asfotase alfa.[2]

Trial status and size

The listed study statuses are Authorised for two trials and Ongoing for one trial.[1][2][3] The planned enrollment is 47 participants in the treatment-naïve pediatric study, 40 in the pediatric safety study, and 122 in the adolescent and adult study.[1][2][3]

Together, these trials show that Alxn1850 is being tested in a staged clinical research program for people with HPP, with separate studies for different ages and prior treatment histories.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2023-505675-73-00 Phase 3 Hypophosphatasia in treatment-naïve pediatric participants Authorised 47
2023-505674-15-00 Phase 3 Hypophosphatasia in pediatric participants previously treated with asfotase alfa Ongoing 40
2023-505673-32-00 Phase 3 Hypophosphatasia in adolescent and adult participants not previously treated with asfotase alfa Authorised 122

FAQ

  • What is being studied in Alxn1850 trials? The trials are studying Alxn1850 in hypophosphatasia, also called HPP. They are checking whether it helps with bone and functional outcomes, and whether it is safe and tolerable.
  • Who can take part in these studies? The studies include pediatric participants, as well as adolescent and adult participants with HPP. Some trials are for people who have never been treated with asfotase alfa, and one is for children who were previously treated with it.
  • What phase are the Alxn1850 trials? All of the listed trials are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to learn more about how well it works and how safe it is.
  • What outcomes are the trials measuring? One pediatric study measures RGI-C score at Day 169, which looks at radiographic change on X-rays. Another adult and adolescent study measures change in the 6-minute walk test, which checks how far a person can walk in 6 minutes. The study in children previously treated with asfotase alfa measures safety events.
  • Are these studies comparing Alxn1850 with another treatment? Yes. Some trials compare Alxn1850 with placebo, which is an inactive product, and one pediatric study compares Alxn1850 with asfotase alfa. This helps researchers see how Alxn1850 performs against other options.

Ongoing Clinical Trials on Alxn1850

  • Study of ALXN1850 for Children Aged 2 to 12 with Hypophosphatasia Who Have Not Previously Received Asfotase Alfa Treatment

    Not yet recruiting

    1 1
    Investigated drugs:
    Belgium Finland France Italy Poland Romania +2

  • Study on ALXN1850 and Asfotase Alfa for Children Aged 2-12 with Hypophosphatasia Previously Treated with Asfotase Alfa

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy

  • Study on ALXN1850 for Adolescents and Adults with Hypophosphatasia Not Previously Treated with Asfotase Alfa

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Italy Poland +2

Glossary

  • Hypophosphatasia (HPP): A rare condition that affects bones. In these trials, it is the disease being studied.
  • Pediatric participants: Children or young people who take part in a clinical study.
  • Adolescent participants: Teenagers who are old enough to be included in a study for older children or young adults.
  • Adult participants: Grown-up people who join a clinical trial.
  • Phase 3: A late stage of testing where a treatment is studied in larger groups to learn more about benefit and safety.
  • Placebo: An inactive product used for comparison in a trial. It looks like the study treatment but does not contain the active study drug.
  • Interventional study: A study in which researchers give a treatment and then measure what happens.
  • Radiographic outcomes: Results seen on imaging tests such as X-rays.
  • RGI-C score: A score used to measure change seen on X-rays in the pediatric study.
  • 6-minute walk test (6MWT): A test that measures how far a person can walk in 6 minutes. It helps show physical function.
  • Safety and tolerability: How well a treatment is handled by the body and what side effects or study events happen.
  • TEAEs, TESAEs, AESIs, and AEs leading to discontinuation or interruption: These are different kinds of unwanted medical events during a study. They help researchers track safety, serious events, special events of interest, and events that cause the treatment to be stopped or paused.

References

  1. https://clinicaltrials.gov/study/2023-505675-73-00
  2. https://clinicaltrials.gov/study/2023-505674-15-00
  3. https://clinicaltrials.gov/study/2023-505673-32-00