Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms

NCT03427060 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AK585
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Outcome Measures

Primary Outcomes (1)

• Measurement of Serum Lactate Dehydrogenase (LDH)

  Measurement of serum lactate dehydrogenase (LDH)

  Baseline to Day 186

Secondary Outcomes (2)

• Percentage Change in Haemoglobin (Hb) Compared to Screening

  Baseline to Day 186

• Number of Packed Red Blood Cells (PRBC) Transfusions

  Baseline to Day 180

Study Arms (1)

Coversin treatment

EXPERIMENTAL

Coversin - 22.5mg followed by 45mg for 6 months.

Drug: Coversin

Interventions

Coversin DRUG

Coversin - 22.5mg followed by 45mg for 6 months.

Coversin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known PNH.
• Aged 18 and above. No upper age limit.
• Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.
• Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.
• Resistance to eculizumab (Soliris®).
• Voluntary written informed consent.
• Willing to self-inject Coversin daily.
• Willing to receive appropriate prophylaxis against Neisseria infection.
• Willing to avoid prohibited medications for duration of study.

You may not qualify if:

• Subjects with body weight \<50 kg (110 lb) or \>100 kg (220 lb).
• Pregnancy or breast feeding (females).
• Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
• Unresolved Neisseria meningitidis infection.
• Patients who have not received adequate immunization against Neisseria meningitides.
• Impaired hepatic function.
• Patients with impaired renal function.
• Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.

Sponsors & Collaborators

• AKARI Therapeutics: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Akari Therapeutics

miles.nunn@akaritx.com

+44 208 004 0261

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 9, 2018
• Study Start: May 14, 2018
• Primary Completion: November 15, 2018
• Study Completion: February 3, 2021
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2024-12

Locations

US (1)