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APL-2 Long Term Safety and Efficacy Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531255
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2018
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Brief Summary:
This is an Open Label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed an APL-2 study.

Condition or disease Intervention/treatment Phase
PNH Drug: APL-2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of APL-2 in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 20, 2022
Estimated Study Completion Date : August 20, 2022


Arm Intervention/treatment
Experimental: 1,080 mg APL-2 administered subcutaneously
1,080mg APL-2 administered subcutaneously twice weekly or every three days.
Drug: APL-2
Complement (C3) Inhibitor




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events [ Time Frame: Baseline to 2 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with PNH who have participated in an APL-2 clinical trial. Subjects who received treatment with APL-2 must have experienced clinical benefit in the opinion of the Investigator.

    • Note: Subjects with PNH who completed an APL-2 clinical trial without receiving APL-2 (or without receiving APL-2 for long enough to demonstrate clinical benefit) may be enrolled in this study if, in the opinion of the Investigator, the subject is expected to demonstrate clinical benefit upon the initiation or continuation of APL-2 therapy.
  • Willing and able to give written informed consent.
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test and must agree to continue to use an approved method of contraception for the duration of the study and 60 days after their last dose of study drug.
  • Males must agree to continue to use an approved method of contraception and must agree to refrain from donating sperm for the duration of the study and 60 days after their last dose of study drug.

Exclusion Criteria:

  • Subjects who have withdrawn from an APL-2 clinical study
  • Any condition that could increase the subject's risk by participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531255


Locations
Show Show 29 study locations
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03531255    
Other Study ID Numbers: APL2-307
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No