Phase III Efficacy, Safety, and Tolerability Study of HyQvia and KIOVIG in CIDP

• Research type

  Research Study

• Full title

  A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

• IRAS ID

  187840

• Contact name

  James Holt

• Contact email

  james.holt@thewaltoncentre.nhs.uk

• Sponsor organisation

  Baxalta Innovations GmbH

• Eudract number

  2014-005496-87

• Clinicaltrials.gov Identifier

  NCT02549170

• Duration of Study in the UK

  3 years, 5 months, 29 days

• Research summary

  Summary of Research
  This clinical trial is investigating two study drugs HyQvia and KIOVIG to treat Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in participants 18 -80 years old with a confirmed
  diagnosis of CIDP. Roughly 232 subjects will be enrolled.
  Both study drugs are already approved in many countries but neither have been approved for the treatment of CIDP. But similar products are approved to treat CIDP. The main purpose of this study is to test if HyQvia is useful to treat CIDP when given as a subcutaneous (SC) (under the skin) self-infusion. The HyQvia will be given as a maintenance treatment, which is a treatment given with the aim to stop a condition from coming back. The second purpose of the study is to test if KIOVIG given intravenously (IV) (directly into a vein) is a treatment option if/when the CIDP returns.

  During the first study period (up to 6 months) the participant will receive a subcutaneous infusion of either HyQvia or placebo. Placebo is a ‘dummy treatment’ with no active drug in. This trial is “randomised” meaning that the participant is randomly allocated to drug or placebo. This phase is also “double-blinded” meaning the participant and doctor will not know which treatment is being received, but the doctor can find out in an emergency. If CIDP gets worse during the first treatment period the participant will be offered to move to a second treatment period. In this the participant will receive an Intravenous infusion of KIOVIG. This is “open-label” meaning the participant and doctor will know the treatment that is being received.
  This is a Phase 3 clinical trial, the study drugs have already been tested in patients but further information will be collected on how well the study drugs work, how safe they are and what type of side-effects may occur.

  Summary of Results
  In conclusion, both Epoch 1 (HYQVIA) and Epoch 2 (Intravenous immunoglobulin G) met their primary endpoint. HYQVIA was more effective than placebo in preventing relapse of neuromuscular disability and impairment, irrespective of age, sex, dosing regimen, and geographic location. GAMMAGARD LIQUID/KIOVIG and Intravenous immunoglobulin G was effective in improving functional ability in subjects who developed a relapse. Both HYQVIA and GAMMAGARD LIQUID /KIOVIG exhibited a favorable safety and tolerability profile

• REC name

  West of Scotland REC 1

• REC reference

  15/WS/0215

• Date of REC Opinion

  15 Dec 2015

• REC opinion

  Further Information Favourable Opinion