Recruiting PHASE1, PHASE2 X-linked Hypophosphatemia

New treatment option for X-linked Hypophosphatemia

Official title A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia

ClinicalTrials.gov ID: NCT06525636

What this study is testing

What is KK8123?

KK8123 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for x-linked hypophosphatemia.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • Part 1:
  • Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
  • Body weight is at least 40 kg.
  • Diagnosed with XLH (as documented by the investigator).
  • Have a value of fasting serum phosphorus \< 2.5 mg/dL (0.81 mmol/L) at Screening.

You likely can't join if

  • Part 1: Exclusion Criteria:
  • For XLH patients previously treated with burosumab, use of burosumab within 7 months prior to ICF signature.
  • Prior history of positive test for human immunodeficiency virus antibody, positive test for hepatitis B surface antigen, and/or hepatitis C virus...
  • History of hypersensitivity to any ingredient of any therapeutic monoclonal antibody.
  • Have an active infection.
  • Grade 3 or greater nephrocalcinosis as confirmed by renal ultrasound.
See the full eligibility criteria
Who can join
  • Part 1:
  • Male or female patients aged 18 to 65 years inclusive at the time of signing the ICF.
  • Body weight is at least 40 kg.
  • Diagnosed with XLH (as documented by the investigator).
  • Have a value of fasting serum phosphorus \< 2.5 mg/dL (0.81 mmol/L) at Screening.
  • Have a value of renal TmP/GFR \< 2.5 mg/dL (0.81 mmol/L) at Screening.
  • eGFR ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration equation [Inker, 2021]) at Screening.
  • Have a corrected serum calcium level \< 10.8 mg/dL (2.7 mmol/L) at Screening.
  • Provide a signed ICF.
  • Agree not to change diet and exercise regimen from one week prior to dosing to end of study.
  • Have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study (female participants only).
  • If taking chronic pain medications (including narcotic pain medications/opioids), must be on a stable regimen for at least 21 days prior to the Screening visit, and be willing to maintain medications at the same stable...
  • Be willing to use a method of contraception following local country guidelines while participating in the study and for 5 months after the last dose (all sexually active participants of childbearing potential). Women of...
  • Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments.
What rules you out
  • Part 1: Exclusion Criteria:
  • For XLH patients previously treated with burosumab, use of burosumab within 7 months prior to ICF signature.
  • Prior history of positive test for human immunodeficiency virus antibody, positive test for hepatitis B surface antigen, and/or hepatitis C virus antibody at Screening.
  • History of hypersensitivity to any ingredient of any therapeutic monoclonal antibody.
  • Have an active infection.
  • Grade 3 or greater nephrocalcinosis as confirmed by renal ultrasound.
  • Uncontrolled diabetes mellitus at Screening.
  • History of known immunodeficiency.
  • History of alcoholism or drug abuse.
  • History of donation of blood within 60 days prior to Screening.
  • Use of any IP or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
  • Use of any therapeutic mAb within 90 days prior to Screening.
  • Use of pharmacologically active vitamin D, its metabolites or analogs, oral phosphate for treatment of XLH, aluminum hydroxide antacids, acetazolamide, thiazide diuretics, and/or systemic corticosteroids within 14 days...
  • Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Screening and for the duration of the study.
  • Use of denosumab within 6 months prior to Screening.
  • Use of oral bisphosphonates in the 2 years prior to Screening.
  • Use of teriparatide or abaloparatide in the 2 months prior to Screening.
  • Plasma iPTH ≥ 2.5 × ULN at Screening.
  • Planned or recommended orthopedic surgery during the study.
  • History of traumatic fracture or orthopedic surgery within 6 months prior to Screening.
  • Participants who are lactating.
  • Current active and symptomatic COVID-19 infection at Day -1.
  • Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study, or that would confound safety or...
  • Completion of relevant cohort in Part 1 of the study.
  • Provide a signed informed consent after the nature of Part 2 of the study has been explained.
  • Body weight is at least 40 kg.
  • Negative pregnancy test at Week 0 of Part 2 and willing to have additional pregnancy tests until the end of the study (female participants only).
  • If taking chronic pain medications (including narcotic pain medications/opioids), must be on a stable regimen for at least 21 days prior to Week 0 of Part 2, and be willing to maintain medications at the same stable...
  • Be willing to use a method of contraception following local country guidelines while participating in the study and for 5 months after the last dose (all sexually active participants of childbearing potential). Women of...
  • Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with all the assessments. Part 2: Exclusion Criteria:
  • Use of burosumab following completion of Part 1 of the study.
  • Have an active infection.
  • Donation of blood within 60 days prior to Week 0 of Part 2.
  • Use of any investigational product other than KK8123, or investigational medical device, within 30 days prior to Week 0 of Part 2, or requirement for any investigational agent prior to completion of all scheduled study...
  • Use of any therapeutic mAb other than KK8123 within 90 days prior to Week 0 of Part 2.
  • Use of pharmacologically active vitamin D, its metabolites or analogs, oral phosphate for treatment of XLH, aluminum hydroxide antacids, acetazolamide, thiazide diuretics, and/or systemic corticosteroids within 14 days...
  • Use of medication to suppress PTH (e.g., calcimimetics) within 2 months prior to Week 0 of Part 2.
  • Use of oral bisphosphonates following completion of Part 1 of the study.
  • Use of teriparatide or abaloparatide in the 2 months prior to Week 0 of Part 2.
  • Planned or recommended orthopedic surgery during the study.
  • History of traumatic fracture or orthopedic surgery within 6 months prior to Week 0 of Part 2.
  • Participants who are lactating.
  • Current active and symptomatic COVID-19 infection, or a history of suffering any long-term sequalae from COVID-19 infection.
  • Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study.

The study team makes the final eligibility decision.

Where it's taking place

  • San Francisco, California, United States
  • New Haven, Connecticut, United States
  • Indianapolis, Indiana, United States
  • Rochester, Minnesota, United States
  • Nashville, Tennessee, United States
  • Le Kremlin-Bicêtre, Paris, France
  • Hamburg, Germany
  • Würzburg, Germany
  • Madrid, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Francisco, California, United States; New Haven, Connecticut, United States; Indianapolis, Indiana, United States; Rochester, Minnesota, United States; Nashville, Tennessee, United States; Le Kremlin-Bicêtre, Paris, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.