RecruitingRare disease

Phase 2 Randomized Study of Povetacicept to Assess Safety and Effectiveness in Adults with Generalized Myasthenia Gravis

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Generalized Myasthenia Gravis is a rare condition in which the immune system mistakenly attacks the connection between nerves and muscles, leading to muscle weakness that can affect the face, eyes, and limbs. The study evaluates the experimental drug povetacicept, which is administered by a subcutaneous injection (a shot placed just under the skin) and compared with a placebo, a substance that looks the same but contains no active medicine.

The purpose of the study is to assess whether povetacicept is safe and well‑tolerated in adults with this disease. Participants are randomly assigned to receive either the study drug or the placebo and attend regular clinic visits over several weeks, during which they receive the assigned treatment and undergo routine health checks.

Key assessments include measuring the level of immunoglobulin G, a type of antibody that helps the immune system, to see how it changes during treatment, and monitoring for any side effects or serious health problems. All observations are recorded to determine the overall safety profile of the medication.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and enrollment
After joining the study, you attend an initial visit where informed consent is confirmed and eligibility is verified.
The study team records your medical history, current medications, and conducts required laboratory tests.
Step 2
Baseline assessments
Baseline data are collected, including a measurement of immunoglobulin g (igg) levels.
These results serve as the reference point for later comparisons.
Step 3
Randomization to study medication
You are assigned, in a blinded manner, to receive either povetacicept or a placebo (test imp without active substance).
The assignment is concealed so you and the study staff do not know which product you receive.
Step 4
First subcutaneous injection
The assigned medication is administered by subcutaneous injection (injection under the skin) using a pre‑filled syringe.
The dose specified in the protocol is 00 mg; the injection schedule follows the study timetable.
Step 5
Regular follow‑up visits and additional injections
You return to the clinic at predetermined intervals to receive further injections of the same study medication.
During each visit, safety is evaluated by asking about any adverse events (unwanted effects) and performing basic health checks.
Step 6
Week 12 evaluation
At week 12, a comprehensive assessment is performed.
The change in immunoglobulin g from the baseline measurement is calculated, and safety is reviewed, including any reported serious adverse events (events requiring medical attention).
Step 7
Long‑term extension (optional continuation)
Participants may continue receiving the study medication beyond week 12 in a long‑term extension phase.
Periodic injections and safety assessments continue according to the extension schedule.

Who can join the trial?

4 criteria

Be between 18 and 80 years old.
Have a diagnosis of generalized myasthenia gravis, a disease that causes the muscles to become weak.
Show generalized muscle weakness (weakness affecting many muscles) and fit into MGFA clinical classification II‑IV, which is a doctor’s system for rating how severe the disease is.
Meet any other requirements that are listed in the study protocol (the detailed plan for the trial).

Who cannot join the trial?

3 criteria

Had surgery on the thymus (a small organ in the chest that helps the immune system) within the past 6 months.
Had cancer (also called malignancy) diagnosed or treated within the past 5 years.
Other reasons that would prevent participation are listed in the study’s detailed plan.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
Poznan, Poland

Trial locations

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Investigated drugs

Povetacicept is an investigational medicine that is given as a liquid injection under the skin. In this study, it is being tested to see if it can safely and effectively help adults with generalized myasthenia gravis, a condition that causes muscle weakness. The drug works by targeting parts of the immune system that are thought to be involved in the disease, with the goal of reducing symptoms and improving muscle strength. Participants receive the medication in a pre‑filled syringe, and researchers closely monitor how the body responds and any side effects that may occur.

Povetacicept

What is already known about the treatment

Test IMP without active substance
This product is a placebo that contains no active drug and is given in the same way as the test medicine, usually by injection, to keep the study blind. It is used only in clinical research to compare against the real medication and has no therapeutic effect. As a control substance, it is not approved for any medical use and appears only in trial protocols. Its role is to help determine whether the active drug works better than doing nothing.
ALPN-303 solution for injection in pre-filled syringe
This medication is a clear liquid that is injected under the skin using a pre‑filled syringe. It is an investigational biologic currently being studied in Phase 2 trials for adults with generalized myasthenia gravis, a rare nerve‑muscle disorder. The drug works by attaching to two proteins (BAFF and APRIL) that help B‑cells make harmful antibodies, thereby lowering the immune attack on the body. It is classified as a fusion‑protein immunomodulator that targets the immune system.

Investigated diseases

Generalized Myasthenia Gravis - Generalized Myasthenia Gravis is an autoimmune condition that weakens the muscles used for movement, facial expression, swallowing, and breathing. The immune system mistakenly attacks the connection between nerves and muscles, reducing the ability of muscles to contract. Weakness often starts in the eyes and spreads to other muscle groups over weeks or months. Symptoms typically become more noticeable after physical activity and improve with rest. The level of weakness can change from day to day, with periods of better and worse function.